TensCare itouch sure Instructions For Use Manual
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INSTRUCTIONS FOR USE
READ CAREFULLY BEFORE USE
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QUICKSTART GUIDE
Connect the unit with the
vaginal probe
Insert the vaginal probe
Press and hold the ON button
to switch the device on
Regulate the output intensity with
the buttons ▲ and ▼
Press and hold the OFF button
to switch the device off
ON
Button P
UP
DOWN
OFF
Select the programme by
pressing the button P
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3 4 5
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Dear Customer,
Thank you for choosing itouch sure. 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
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Contents
1. INTRODUCTION ................................................................................................. 6
2. INTENDED USE .................................................................................................. 6
3. ITOUCH SURE FEATURES ................................................................................ 7
4. PELVIC FLOOR EXERCISES ............................................................................. 7
4.1. PELVIC FLOOR MUSCLES .......................................................................... 7
4.2. PERFORMING PELVIC FLOOR EXERCISES ............................................. 9
5. TYPES OF INCONTINENCE ............................................................................. 10
6. HOW ‘EMS’ WORKS ......................................................................................... 10
7. CONTRAINDICATIONS, WARNINGS & CAUTIONS ........................................ 11
8. INFORMATION ABOUT THE PROGRAMME SETTINGS ................................ 14
9. PROGRAMMES ................................................................................................ 15
9.1. PROGRAMME SETTINGS ......................................................................... 15
9.2. PRESET PROGRAMMES .......................................................................... 15
10. CONTENT ......................................................................................................... 16
11. UNIT INFORMATION ........................................................................................ 17
11.1. CONTROLS & DISPLAY ......................................................................... 17
11.2. OPERATING INSTRUCTIONS ................................................................ 18
12. SETTING UP AND USING THE ITOUCH SURE ............................................... 20
12.1. INSTALLATION OF BATTERIES ............................................................. 20
12.2. CONNECTING LEAD WIRE .................................................................... 21
12.3. PREPARING FOR SESSION .................................................................. 21
12.4. TRAINING SESSION ............................................................................... 22
12.5. AFTER YOUR TRAINING SESSION ....................................................... 24
13. ANAL PROBE .................................................................................................... 24
13.1. CONDITIONS THAT MAY BE TREATED ................................................ 24
13.2. HOW TO INSERT THE ANAL PROBE .................................................... 25
14. CLEANING ........................................................................................................ 25
15. EMC ................................................................................................................... 26
16. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS ........ 26
17. ACCESSORIES ................................................................................................. 26
18. WARRANTY ...................................................................................................... 27
19. TROUBLESHOOTING ....................................................................................... 29
20. GENERAL SPECIFICATION ............................................................................. 31
NOTES ..................................................................................................................... 33
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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.
Lot Number: indicates the manufacturer’s batch code so that the batch or lot can
be identified.
Humidity Limitation: indicates the humidity limits to which the medical device can
be safely exposed.
Serial Number: indicates the manufacturer’s serial number so that a specific
medical device can be identified.
Do not dispose in household waste.
Catalogue Number: indicates the manufacturer’s catalogue number so that the
device can be identified.
This medical device is not water resistant and should be protected from liquids.
Atmospheric Pressure: indicates the atmospheric limits to which the medical device
can be safely exposed.
Date of Manufacture: indicates the date which the medical device was
manufactured. This is included within the serial number found on the device
(usually in the battery compartment), either as “E/Year/Number” (YY/123456) or
“E/Month/Year/Number” (MM/YY/123456).
This medical device is indicated for home use.
The first number 2: Protected against access to hazardous parts with a finger,
and the jointed test finger of 12 mm ø, 80 mm length, shall have adequate
clearance from hazardous parts, and protected against solid foreign objects of 12.5
mm ø and greater.
The second number 2: Protected against vertically falling water drops when
enclosure is tilted up to 15˚. Vertically falling drops shall have no harmful effects
when the enclosure is tilted at any angle up to 15˚ on either side of the vertical.
LOT
S/N
REF
IP22
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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 itouch sure 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 itouch sure 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 itouch sure is very easy to use,
with four clearly labelled preset training
programmes and a simple push button
control.
The itouch sure 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.
• Treatment of erectile dysfunction
in men* and improvement of pelvic
strength (* requires an anal probe).
2. INTENDED USE
Itouch sure 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.
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3. ITOUCH SURE
FEATURES
• Single Channel
Single channel unit provides relief from
symptoms of all types of incontinence
via a tampon-shaped probe.
• Comfortable Stimulation
Gentle stimulation in small steps of
intensity, 0.5 mA per step.
• 4 Preset 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 muscles are not
overworked. The user can manually
reset this (20,30,45,60 or 90 mins).
• Open Circuit Detection
Automatically resets the strength to
zero and flashes ‘LEADS’ if the
connection comes loose.
• Keypad Lock
Enables the user to manually lock the
controls to prevent any accidental
changes in settings.
• 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), number of uses and
time of usage.
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.
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
o provide support for the baby
during pregnancy and
o assist in the birthing process
Pelvic floor muscles are also important
for sexual function in both men and
women:
• In men, it is important for erectile
function and ejaculation.
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• 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.
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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 itouch sure 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.
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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 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.
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 noninvasive method of producing
contraction of muscles via a gentle
stimulation to the pelvic floor through a
discreet probe or electrode pads when
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