TensCare Perfect PFE Instructions For Use Manual

0

INSTRUCTIONS FOR USE

READ CAREFULLY BEFORE USE

1

QUICKSTART GUIDE

Connect the unit to the anal

probe

Insert the anal probe until the base

of the flange touches the anus

You can adjust the position of the

flange

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

1

2

3 4 5

6

2

Dear Customer,

Thank you for choosing perfect PFE. 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

3

4

Contents

1. INTRODUCTION ................................................................................................. 6

2. INTENDED USE .................................................................................................. 6

3. PERFECT PFE FEATURES ................................................................................ 7

4. PELVIC FLOOR EXERCISES ............................................................................. 7

4.1. PELVIC FLOOR MUSCLES .......................................................................... 7

4.2. PERFORMING PELVIC FLOOR EXERCISES ............................................. 8

5. TYPES OF INCONTINENCE ............................................................................. 10

6. HOW ‘EMS’ WORKS ......................................................................................... 11

7. HOW ‘TENS’ WORKS ....................................................................................... 12

8. CONTRAINDICATIONS, WARNINGS & CAUTIONS ........................................ 13

9. INFORMATION ABOUT THE PROGRAMME SETTINGS ............................... 15

10. PROGRAMMES ............................................................................................. 16

10.1. PROGRAMME SETTINGS ...................................................................... 16

10.2. PRESET PROGRAMMES ....................................................................... 16

11. CONTENT ...................................................................................................... 17

12. UNIT INFORMATION ..................................................................................... 18

12.1. CONTROLS & DISPLAY ......................................................................... 18

12.2. OPERATING INSTRUCTIONS ................................................................ 19

13. SETTING UP AND USING THE PERFECT PFE ........................................... 21

13.1. INSTALLATION OF BATTERIES ............................................................. 21

13.2. CONNECTING LEAD WIRE .................................................................... 22

13.3. PREPARING FOR SESSION .................................................................. 22

13.4. TRAINING SESSION ................................ ............................................... 23

13.5. AFTER YOUR TRAINING SESSION ....................................................... 25

14. CLEANING ..................................................................................................... 25

15. EMC ............................................................................................................... 25

16. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS

(WEEE) .................................................................................................................... 25

17. ACCESSORIES ............................................................................................. 26

18. WARRANTY ................................................................................................... 27

19. TROUBLESHOOTING ................................................................................... 28

20. GENERAL SPECIFICATION .......................................................................... 30

NOTES ..................................................................................................................... 33

5

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

6

1. INTRODUCTION

Device Description & Principles of
Design

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

The perfect PFE 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 an
anal probe with stainless steel
electrodes or with optional electrode
pads. 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 perfect PFE can work
them f or you to build up their strength
and help you to develop your own
muscle control. It perfectly
complements pelvic floor exercises.
The perfect PFE is very easy to use,
with f our clearly labelled preset training
programme s, a fifth programme for
chronic pelvic pain and a simple push
button control.

The perfect PFE 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.

• Chronic prostatitis/chronic pelvic
pain syndrome: unexplained

chronic pelvic pain associated with
irritative voiding symptoms and/or
pain located in the groin, genitalia, or
perineum in the absence of pyuria
and bacteriuria.

• Treatment of erectile dysfunction
in men and improvement of pelvic

strength.

Also, can be used for non-medical
purposes to:

• maintain a healthy bowel movement

• achieve a more satisfying erection

• improve rectal sensation for

enhanced pleasure

• improve pelvic strength

2. INTENDED USE

Perfect PFE is a medical

device designed to be used in

the home healthcare
environment to treat symptoms of
urinary and/or faecal incontinence and
to treat erectile dysfunction and is
suitable f or use by all who can control
the device and understand the
instructions.

Perfect PFE may help to relieve
symptoms of chronic prostatitis/chronic
pelvic pain.

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

Warning: Not suitable for use in

children without medical

supervision.

7

3. PERFECT PFE
FEATURES

• Single Channel

Single channel unit to treat symptoms
of urinary and faecal incontinence via
an anal probe with adjustable depth.

• Comfortable Stimulation

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

• 5 Preset Programmes

EMS programmes including STRES,
URGE, MIXED and TONE aftercare;
and additional TENS progra mme
providing relief from prostatitis pain and
pelvic pain.

• Memory

Features 3 functions: programme
retention (automatically starts in the last
programme used), number of uses and
time of usage.

• Treatment Timer

Unit def aults to 20 minutes’ treat ment to

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

• Open Circuit Detection

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

• Automatic Keypad Lock

Automatic keypad lock prevents any
accidental changes in settings.

• Large LCD Screen

Clearly shows the operation of the unit
and the progra mme and intensity being
used.

4. PELVIC FLOOR
EXERCISES

4.1. PELVIC FLOOR

MUSCLES

The “FLOOR” of your pelvis is made up

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

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.

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

• In men, it is important for erectile

function and ejaculation.

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.

8

Pelvic floor muscles can be made
weaker by:

• Certain treatments for prostate
cancer (surgery, radical
prostatectomy or transur ethral
resection of the prostate TURP);

• Constipation;

• Being overweight;

• Heavy lifting;

• Coughing that goes on f or a long

time (such as smoker's cough,
bronchitis or asthma); or

• Not being fit.

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 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.

Men with stress incontinence – that is,
men having bladder leakage when they
cough, sneeze or are active – will find

pelvic floor muscles training can help in
getting over this problem.

Pelvic floor muscles training may also
be of use for men who have an urgent
need to pass urine more often (called
urge incontinence).

Men who have problems with bowel
control might find that training their
pelvic floor can help the muscle that
closes the back passage. This muscle
is one of the pelvic floor muscles.

It can also reduce your risk of prolapse,
improve your recovery from urology
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 (someti mes called Kegel
Exercises) part of your daily lif e.

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 f or 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 is a technique which might
help:
Try to stop the flow of urine during
urination. If you are successf ul, then
you know you are exercising the
correct muscles.

9

Note: This technique is just to

help you confir m that you are

using the correct muscles. It is
important to have an empty bladder
bef ore starting the exercises.

Pelvic floor exercises can be done
anywhere and anytime. You can
perfor m them standing, squatting or
lying down but at first you may find it
easier to do the exercises sitting down:

• Sit on a chair, toilet seat or toilet lid.

• Make sure that your feet are flat on

the floor and your legs are slightly
apart.

• Lean forwards, resting your elbows

on your knees.

There are two types of exercises – slow
twitch and fast twitch. It is important that
you do the slow twitch first and then the
fast twitch each time you exercise your
pelvic floor muscles.

To perform the slow twitch
exercises:

1) Close and draw up the muscles
around back passage, as if you are
trying to stop passing wind. Make sure
that you do not contract (tighten) your
buttock muscles while you do this.

2) Now close and draw up the muscles
around your urethra, as though you are
trying to stop the flow of urine.

3) Try not to hold your breath, breathe
nor mally. Pull upwards and count how
long you can hold the squeeze. If you
can hold for a count of 10, then relax f or
a count of 10.

4) Repeat this until you feel tired.

5) Over time you should be able to
increase the length of time you can hold
for.

To perform the fast twitch exercises:

1) Pull up the pelvic floor muscles as
bef ore.

2) Hold for one second and then relax.

3) Repeat until your muscles feel tired.
Pelvic floor muscles tire easily and you

may notice that it takes a lot of
concentration to begin with to do these
exercises correctly. If you find that the

muscles ‘let go’ too quickly and that you

cannot hold for long, just hold them for
as long as you can. If you can only hold
the contraction for a count of three, then
every time you do your exercises,
contract the muscles for a count of
three. Gradually try to work up to f our,
then five and so on. Once you f eel
confident in doing the exercises try
doing them in other positions, such as
standing or squatting.

Remember to tighten your pelvic floor
muscles during and after any activity
that makes you leak – like rising from a
chair or coughing – so that tightening
becomes an automatic reaction.

While perfor ming the exercises, it is
important not to:

● Squeeze your buttocks together

● Bring your knees together

● Hold your breath

● Lift your shoulders, eyebrows or toes

upwards

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

10

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.

Using your perfect PFE 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 men after
radical prostatectomy 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.

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 ai m to
progress towards graduated active
exercises, in order to improve pelvic
floor muscle strength and endurance
and to regain f unction.

You may benefit from the perfect PFE
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 perfect PFE.

Post Prostatectomy Urinary
Incontinence

Electrical stimulation has been found to
help urinary incontinence in men after
radical prostatectomy in some trials.
Choose the progra mme depending on
the type of incontinence you are
suffering from and increase the
intensity to the highest tolerable.

Chronic prostatitis/chronic pelvic
pain syndrome: unexplained chronic

pelvic pain associated with irritative
voiding symptoms and/or pain located
in the groin, genitalia, or perineum in
the absence of pyuria and bacteriuria.

Low frequency stimulation stimulates
the release of Endorphins – your body’s
natural pain relief mechanis m – to
reduce pain without side effects.