Elise 2 Instructions For Use Ver 1.0 July 2020

QUICKSTART GUIDE Read instructions for use and warnings carefully prior to use.

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1

Go to the toilet before use. Choose a comfortable position, such a leaning back or lying down on your bed with your knees raised. Connect the unit with the vaginal probe

Firstly, test the unit with the probe in your hand–hold the probe tightly, covering as much of the metal plates on the probe with your skin. Then insert the vaginal

probe (lubricate with a water-based lubricant or water)

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ON

4 Button P

Select the programme by pressing the button P

Press and hold the ON button to switch the device on

5 DOWN

OFF

6

UP

Regulate the output intensity with + and -

Press and hold the OFF button to switch the device off

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Dear Customer, Thank you for choosing the TensCare Elise 2. TensCare stands for highquality, 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

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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

5. TYPES OF INCONTINENCE ... 9 6. HOW ‘EMS’ WORKS ... 10 7. CONTRAINDICATIONS, WARNINGS & CAUTIONS ... 11 8. INFORMATION ABOUT THE PROGRAMME SETTINGS ... 14 9. PROGRAMMES ... 14 9.1

PROGRAMME SETTINGS ... 14

9.2.

PRESET PROGRAMMES ... 14

10. CONTENT ... 16 11. UNIT INFORMATION ... 17 11.1.

CONTROLS & DISPLAY ... 17

11.2.

OPERATING INSTRUCTIONS ... 18

12. SETTING UP AND USING THE ELISE 2 ... 20 12.1.

CHARGING THE BATTERY ... 20

12.2.

CONNECTING LEAD WIRE ... 21

12.3.

PREPARING FOR SESSION ... 21

12.4.

TRAINING SESSION ... 22

12.5.

AFTER YOUR TRAINING SESSION ... 23

13. ANAL PROBE ... 24 13.1.

CONDITIONS THAT MAY BE TREATED ... 24

13.2.

HOW TO INSERT THE ANAL PROBE ... 24

14. CLEANING ... 25 15. EMC... 25 16. DISPOSAL ... 26 17. ACCESSORIES ... 26 18. WARRANTY ... 27 19. TROUBLESHOOTING... 29 20. GENERAL SPECIFICATION ... 31

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SYMBOLS USED Attention! Please follow the instructions in the user’s instructions for use.

TYPE BF EQUIPMENT: 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. Humidity Limitation: indicates the humidity limits to which the medical device can be safely exposed. Atmospheric Pressure Limitation: indicates the atmospheric limits to which the medical device can be safely exposed. Lot Number: indicates the manufacturer’s batch code so that the batch or lot can be identified. Serial Number: indicates the manufacturer’s serial number so that a specific medical device can be identified. Catalogue Number: indicates the manufacturer’s catalogue number so that the device can be identified. Do not dispose in household waste.

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 or in the battery compartment, either as “E/Year/Number” (YY/123456) or “E/Month/Year/Number” (MM/YY/123456). CE Mark 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 ø, 80 mm length, shall have adequate clearance from hazardous parts, and protected against solid foreign objects of 12.5 mm ø and greater.

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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.

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1. INTRODUCTION

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.

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.

2. INTENDED USE

The Elise 2 is a powered muscle stimulator used for strengthening the pelvic floor muscles.

Elise 2 has been designed to be a medical device used in the home healthcare environment to treat urinary and/or faecal incontinence using gentle electrical stimulation (i.e. EMS – electrical muscle stimulation).

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.

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.

The Elise 2 provides relief from conditions such as:

• Comfortable Stimulation

• 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.

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.

• Anal stimulation (requires an anal probe) may also help men who are otherwise unable to execute Kegel 6

• Treatment Timer

• Work with the abdominal and back muscles to stabilise and support the spine. • In women, also o provide support for the baby during pregnancy and o assist in the birthing process

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.

Pelvic floor muscles are also important for sexual function in both men and women:

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

• In men, it is important for erectile function and ejaculation. • In women, voluntary contractions (squeezing) of the pelvic floor contribute to sexual sensation and arousal.

4. PELVIC FLOOR EXERCISES

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.

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.

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.

The pelvic floor muscles: • Assist in supporting the abdominal and pelvic organs. 7

Common signs that can indicate a pelvic floor problem include:

increase your sexual pleasure. A continence therapist can help you learn how to exercise your pelvic floor.

• 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

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

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. 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.

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,

It can also reduce your risk of prolapse, improve your recovery from childbirth and gynaecological surgery, and 8

5. TYPES OF INCONTINENCE

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.

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.

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.

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.

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.

Mixed Incontinence Is a combination of both Stress and Urge Incontinence. Incontinence can have many causes. You should try to identify the type of incontinence and the cause before starting to use this device with your healthcare professional.

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6. HOW ‘EMS’ WORKS

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.

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 wellestablished 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.

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.

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

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.

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.

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.

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 noninvasive 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 10

7. CONTRAINDICATIONS, WARNINGS & CAUTIONS

Do NOT use when walking, 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 and put you at risk of injury.

If in doubt, contact your healthcare professional before using the Elise 2.

CONTRAINDICATIONS:

Do NOT use to mask or relieve undiagnosed pain. This may delay diagnosis of a progressive condition.

Do NOT use if you are or may be pregnant; or in the first 6-8 weeks after childbirth or pelvic surgery. It is not known whether EMS may affect foetal development. Stimulation may disrupt the healing process.

Do NOT use if you have, active or suspected vaginal, pelvic or prostate cancer or undiagnosed pain in the area being treated 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 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 optional electrode pads near the thorax as this may increase the risk of cardiac fibrillation.

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 optional electrode pads 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 if you have poor sensation in the pelvic region. You may not be able to control the intensity of stimulation safely

Do NOT use optional electrodes across the chest. Very strong stimulation across the chest may cause an extra heartbeat.

WARNINGS:.

Do NOT use Elise 2 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 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. 11

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.

Caution: Keep away from children under 5 years of age. Long cord - 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

CAUTIONS: Caution should be used if you have a bleeding disorder as stimulation increases blood flow to the stimulated region. Caution should be used if you have suspected or diagnosed epilepsy as electrical stimulation may affect seizure threshold.

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.

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: Simultaneous connection to high frequency surgical equipment may result in burns and damage to the stimulator.

PROBE CAUTIONS: Caution: The Elise 2 vaginal or anal probe is intended for single patient use only. Do not share your Elise 2 probe with anyone else. Improper treatment or crossinfection may occur.

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

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

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

Caution: Insertion of the vaginal or anal probe makes it unsuitable for use in children without clinical supervision. 12

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

immediately, as this type of electrodes may not be suitable for you. 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 a siliconebased lubricant on the metal plates of the probe as it may decrease the effectiveness of Elise 2’s muscle stimulation. Only use waterbased.

Caution: Do not use high intensity settings if electrodes are smaller than 50x50mm.

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 XVPG).

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: Do not use this device with a vaginal 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 ELECTRODE PADS:

Caution: Keep the device away from sunlight, as longterm exposure to sunlight may affect the rubber causing it to become less elastic and crack.

OPTIONAL

• 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. • The electrode pads are reusable but for single patient use. The adhesive is a peel- able hydrogel (waterbased).

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 transport & storage: -25°C to 70°C, up to 93% R.H. Temperature & Relative Humidity of operation: 5°C to 40°C, 15% to 93% R.H.

ELECTRODE PADS CAUTION: Caution: Do not ignore any allergic reaction to the electrode pads: If a skin irritation develops, stop use

Caution: Do not attempt to open or modify the unit. This 13

9. PROGRAMMES 9.1

PROGRAMME SETTINGS

Prog

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.

STRES URGE MIXED

TONE

Freq. (Hz)

50

10

10/ 50

35

Pulse width (μs)

300

200

200/ 300

250

Ramp Up & Down (s)

1

Con/ 1

2

Plateau (s)

5

Con/ 5

3

Rest (s)

10

6

Default duration (min)

20

Con/ 10 10/ 10

Constant

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

Continuous

may affect the safe operation of the unit and will invalidate the warranty.

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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).

Medium frequencies (20-50 Hz) can put a high level of strain on the muscle, thus promoting the muscular structure. • Pulse Width (measured in μs millionths of a second)

STRESS INCONTINENCE:

The Elise 2 unit has pulse widths of 200 to 300 μs. 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.

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, 14

successful treatment requires stimulation once a day for one to three months. Improvement starts becoming apparent after about four weeks.

For the URGE program 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 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, thereby exercising and strengthening them.

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.

For the STRESS program the muscle MUST contract in order to give a benefit. Increase the strength as high as is comfortable and then take it down one step.

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.

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.

Note: 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.

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

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

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.

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.

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10. CONTENTS

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

The pack contains:

For the TONE program the muscle MUST contract in order to give a benefit. Increase the strength as high as is comfortable and then take it down one step.

1 x Elise 2 Pelvic Floor Exerciser 1 x Lead wire (L-ELGR) 1 x Short probe lead (L-VPCE) 1 x Liberty probe (X-VP) 1 x USB charging cable (X-ELISE2USB) • 1 x Storage pouch • 1 x Instructions for use booklet • • • • •

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11. UNIT INFORMATION 11.1. CONTROLS & DISPLAY

ON/OFF button

Programme duration (min) Programme selected Strength selected (mA) Programme selector

Strength down

Strength up

Time selector

USB charging cable and lead wire input

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11.2. OPERATING INSTRUCTIONS

The strength levels are shown on the LCD.

ON/OFF

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.

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.

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.

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:

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.

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

PROGRAMME CONTROL

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

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.

P

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

+ -

Each time you press and release the P button, the programme changes and is shown on the LCD.

The buttons marked + and - are the strength controls.

To increase strength, press and hold down the button + until required strength is achieved.

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.

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. 18

TREATMENT TIMER

Check the lead and if necessary, lubricate the probe with a water-based lubricant or water. Please see section 19 for more troubleshooting tips.

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.

T

MEMORY

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

The Elise 2 has a Memory with three functions:

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.

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.

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.

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.

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.

Time used in 10 minute intervals

Average strength used

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. 19