Body Clock Health Care Femme Elite User manual

Femme Elite
Instructions for use
Pelvic Floor Stimulator,
TENS Pain Reliever and
EMS Muscle Toner
The 3-in-1

The Femme Elite can be used
for pain relief (TENS), muscle
toning (EMS) and pelvic floor
stimulation (PFS).
t is designed for use by all women, in
every stage of life.
The Femme Elite is completely drug
free, meaning there are no nasty side
effects, allowing you to live life to the
full.
Before you use the Femme Elite, it is
important that you read this manual
carefully; it contains all the information
you need to ensure you are using the
unit safely and correctly.
Explanation of Symbols on Unit
Equipment providing a particular degree
of protection against electric shock partic-
ularly regarding allowable leakage
currents having an F type (floating)
applied part.
Warning - refer to page 4 of these
instructions.

Contents
Precautions and contraindications ....................4
The Femme Elite controls ..................................5
Display symbols and their meanings ................5
Setting up your Femme Elite ..............................6
Useful diagrams ................................................7
PFS - Pelvic Floor Stimulation
ncontinence - the facts ......................................8
When to use PFS ..............................................9
Using the Femme Elite for PFS ..........................9
PFS FAQ’s..........................................................10
TENS - Pain Relief
About TENS ......................................................11
What can TENS be used for?..............................11
Using the TENS mode ......................................12
Electrode pad placement ..................................12
FAQ’s and troubleshooting ..............................13
EMS - Muscle Toning
About EMS........................................................14
What can EMS be used for? ..............................14
Using the EMS mode ......................................15
Electrode pad placement ..................................15
EMS FAQ’s ........................................................16
Technical data ..................................................17
Useful contacts ................................................18
3

Precautions and contraindications
1. Do NOT use the Femme Elite if you have a
cardiac pacemaker.
2. Check with your medical adviser before using
if you suffer from a heart condition,
undiagnosed pain, have any metal implants,
or any doubts whatsoever.
3. TENS can NOT be used before the 37th week of
pregnancy.
4. EMS and PFS can NOT be used during
pregnancy. You are able to use them from 12
weeks after the birth.
5. Do NOT use the PFS internal probe if you
suffering from any urinary or vaginal infection.
6. Do NOT use PFS at the same time as a barrier
contraceptive device such as a diaphragm or
cervical cap.
f you have any concerns regarding use of the
Femme Elite please do not hesitate to contact Body
Clock Health Care on 020 8532 9595.
General Precautions
1. Do NOT use this unit without first reading these
instructions.
2. Do NOT immerse the Femme Elite in any liquid.
3. Do NOT place it close to any source of
excessive heat.
4. Do NOT operate this unit in the presence of
flammable gas.
5. Do NOT attempt to open the Femme Elite.
6. Only use the specified batteries and electrodes.
7. f damaged as in general precautions
2-5 above, do NOT use. Contact supplier.
8. Remove the batteries when the Femme Elite is
not in use.
9. Do NOT use while driving or operating
potentially dangerous machinery.
10. Keep the Femme Elite out of the reach of children.
4

5
Controls on the Femme Elite
User display (also see diagram below).
MODE selector - Found on the side of the
Femme Elite. t enables you to switch between
the PELV (Pelvic Floor Stimulation), TENS and
EMS modes.
PROG key - Press the ‘PROG’ key to alter the
programmes in the ‘PFS’, ‘TENS’ or ‘EMS’
modes.
ON/UP key - Press the ‘ON/Up’ key to either
turn on the Femme Elite or increase the
intensity of the pulses.
down/OFF key - Press the ‘down/OFF’ key to
either turn off the Femme Elite or decrease the
intensity of the pulses. n order to switch the
Femme Elite off, either turn the intensity down
all the way until the unit switches off, or press
‘PROG’ key once and then the ‘down/OFF’ key.
Display symbols and their meanings
Mode indicator
ndicates mode in use
Programme indicator
ndicates programme in
use
ntensity indicator
For further assistance contact the
helpline on 0845 230 9737
PELV TENS TONE
1
1
1
2
3
4
5
2
3
4
5

Setting up your Femme Elite
Check the following contents:
1 x Femme Elite unit
1 x Pack of 4 self adhesive electrodes
1 x Leadwire adaptor
1 x Elite vaginal probe
1 x Lithium battery
1 x Lubricant gel sachet
1 x Carrying Pouch
The assembly stage
a) Slide open the battery cover on the back of the
unit and insert the battery, ensuring the
positive (+) side is visible and facing upward.
Replace the cover (see fig. 1, page 7).
b) Connect the leadwire adaptor to the Femme
Elite unit by inserting the protruding pin on the
adaptor into the holes on the back of the
Femme Elite. Slide upwards to ensure it is fixed
securely (see fig. 2, page 7).
When using the Pelvic Floor
Stimulation mode.
• Connect the Elite vaginal probe according to the
instructions found in probe packaging.
• Switch the Mode Selector to ‘PELV’.
When using the TENS and EMS modes.
• Connect the pin ends of the leadwire adaptor
into the electrodes (see fig. 2, page 7).
• Switch the Mode Selector to ‘TENS’ or ‘EMS’.
6

7
Useful Diagrams

8
PFS -Pelvic Floor Stimulation
PFS helps to strengthen the Pelvic Floor muscles.
Like all other muscles in your body, the more you
stimulate them, the stronger they become. Women
with strong pelvic floor muscles enjoy greater
control over their bladder, increased vaginal tone
and greater sensation during intercourse.
One in three women suffer from some form of
incontinence during their lives. t can occur at any
time, most commonly after childbirth. The severity
of incontinence can vary.
There are three types of incontinence, all of which
can be treated with the Femme Elite;
1. Stress incontinence - occurs when sneezing,
coughing, laughing, lifting or during exercise
and causes a small amount of urine to leak.
2. Urge incontinence - occurs with a strong, sudden
and uncontrollable urge to urinate.
3. Mixed incontinence - a combination of urge and
stress incontinence.
The Femme Elite is designed to stimulate and
strengthen your pelvic floor muscles for you. t has
3 PFS programmes; each treats a different type of
incontinence.
PELV 1 Urge ncontinence
PELV 2 Stress ncontinence
PELV 3 Mixed ncontinence
The internal probe supplied will ensure you are
stimulating the correct area. The Femme Elite works
like an internal muscle toner to strengthen the
pelvic floor muscles.
Before first use of the Femme Elite, please
familiarise yourself with the warnings and
contraindications contained on page 4.

9
When to use PFS
Below is a guide showing how often to use the PFS
mode on your Femme Elite. f your muscles start to
ache, or you have any problems using the Femme
Elite, please contact your medical adviser.
DO NOT EXCEED RECOMMENDED TREATMENT TIMES
UNLESS ADVISED BY A MEDICAL PROFESSIONAL.
Do NOT commence treatment until you have read
and understood the instruction manual provided
with the internal vaginal probe.
Using the Femme Elite for PFS.
a) Ensure that the Mode Selector is switched to ‘PELV’.
b) nsert the vaginal probe as illustrated in the
instruction manual, found in the probe packaging.
c) Switch the unit on.
d) Select the Programme, designed for your type of
incontinence by using the ‘PROG’ key.
e) Gradually increase the intensity until you can
comfortably feel the muscles contacting.
f) At the end of the programme, the Femme Elite
will automatically switch off.
g) After you have finished remove and thoroughly
clean the vaginal probe in accordance with the
vaginal probe instruction manual.
The Femme Elite should NOT be used:
• During the menstrual period
• f you suffer a urinary or vaginal infection
• At the same time as a barrier contraceptive
device such as a diaphragm or cervical cap
Programme Length How often
PELV 1 30 min 1-2 times a day.
PELV 2 30 mins Once a day or every other
day depending of severity.
PELV 3 60 mins Complete the programme
once a day.

10
PFS -Frequently Asked uestions
QWhat does it feel like?
A All three PFS programmes feel slightly different.
n general, the feeling is that of a pleasant tingly
squeezing sensation that contracts and relaxes
the pelvic floor muscles.
QIs it suitable for use by all women?
A Yes, all women can use it provided none of the
contraindications apply.
QCan I use it whilst I’m pregnant?
A No, not until 12 weeks after the birth.
QAre there any side effects?
A No, it is totally drug free. There are no known
side effects.
QHow long will it take to see results?
A The amount of time varies from woman to
woman; it is also dependent on the type of
incontinence from which you are suffering.
STRESS Incontinence - improvement comes
slowly with the building of muscle fibre and
nerve sensitivity. This can take up to 2 months.
URGE Incontinence - improvements are made by
reducing the false signals sent by the bladder to
the brain. Results can be seen in as little as 14
days.
MIXED Incontinence - improvements are made
by building the muscle fibre and nerve sensitivity
as well as reducing the false signals being sent
to the brain. This can take slightly longer, but you
should be able to notice a difference within 21
days.
f you have any further questions on incontinence or
need some advice, contact The Continence Foundation
on:
Helpline: 0845 345 0165
e-mail: [e-mail]
web: www.continence-foundation.org.uk
Registered Charity No. 1014429
Reg Charity 1014429

11
TENS - for pain
TENS (Transcutaneous Electrical Nerve Stimulation)
works by passing mild electrical impulses through
the skin, into the nerve fibres which lie below, via
electrodes pads. TENS impulses help your body
produce its own pain killing chemicals, such as
‘endorphins’.
What can TENS be used for?
TENS can be used for many chronic and acute pain
conditions such as period pain, back pain, shoulder
pain, arthritis, sciatica, sports injuries, migraine
and post operative pain.
f this is the first time you are using your Femme
Elite, you need to set up the unit - see page 6.
Ensure that the mode selector is switched to ‘TENS’
before commencing treatment.
The Femme Elite has 4 TENS programmes, each
treats a different type of pain.
TENS 1 Back Pain
TENS 2 Migraine
TENS 3 Period Pain
TENS 4 Shoulder Pain
f you prefer, you can use any of the TENS
programmes to treat your pain. The above table
shows which pain areas the programmes are
commonly used for.
For more information on which conditions TENS can
treat, or for alternative electrode placement advice
please call Body Clock Health Care on
0208 532 9595 or visit www.bodyclock.co.uk.
Before first use of the Femme Elite, please
familiarise yourself with the warnings and
contraindications contained on page 4.

12
Using the Femme Elite TENS mode
To commence treatment carefully peel the
electrodes from the plastic backing, using your
forefinger and thumb. Place them on you body as
shown in the diagrams below. The ‘black squares’
represent where to place the electrodes.
Once the electrodes are positioned correctly, switch
the unit on. ‘TENS’ should then appear on the
screen. f it does not, switch the unit off and adjust
the mode selector to ‘TENS’ and switch the unit on
again.
You can then choose your programme using the
‘PROG’ key. Once you have selected your
programme gradually increase the intensity, using
the ‘ON/Up’ key, until the pulsing sensation is
comfortable.
TENS Programme 1 -
Back Pain
TENS Programme 2 -
Migraine
TENS Programme 3 -
Period Pain
TENS Programme 4 -
Shoulder Pain
Can be used with both pads
on the same side or 1 pad on
either side.
Lower
Pack Pain
Upper
Back Pain
Period
Pain
Period and
Back Pain

1313
TENS - Frequently Asked uestions
QIs it safe?
Yes, TENS is used widely for pain relief and is
recommended by medical professionals.
QCan I use it with other medications?
A Yes. TENS is drug free so you can use it with any
other medication including paracetamol.
QWhat conditions can TENS be used to treat?
A TENS can be used to treat numerous pain
conditions. To find out whether you are able to use
TENS please consult your medical adviser or
contact Body Clock Health Care on 020 8532 9595.
QCan I use this TENS for labour?
A t is not recommended. t does not feature the
booster button required for use during contractions.
For information on TENS for use during labour,
please visit www.BabycareTENS.com or call
0845 230 9737.
Troubleshooting uestions.
QWhy does the pulse sensation not appear to be
as strong after you have used the Femme Elite
for a while?
A ncrease the intensity, you may have become
used to a lower setting.
QWhy does the pulse sensation feel strong but
ineffective?
A You may need to reposition the electrode pads.
QWhy does the sensation not feel sufficiently
strong even on a high setting?
A The batteries may need replacing.

EMS - For Muscle Toning
EMS (Electro Muscle Stimulation) is a method of
passing electrical impulses through the skin to the
muscles which lie beneath, causing them to
contract and relax, thereby improving muscle tone.
Most women feel that there is some part of their
body that they would like to be more toned. Using
the Femme Elite is the easy way to help get rid of
those problem areas.
What can EMS be used for?
Toning and building all muscle groups. Apart from
its many cosmetic uses it can be used to treat
sports injuries or to treat muscle wastage. The
Femme Elite is commonly used after childbirth to
recover and build the abdominal muscles. t has 3
different EMS modes, each is a specifically
designed exercise programme for the muscle
groups women tend to want to treat e.g. abdominal
and thigh muscles.
f this is the first time you are using your Femme
Elite, you need to set up the unit - see page 6.
Ensure that the mode selector is switched to ‘EMS’
before commencing treatment.
The Femme Elite has 3 EMS programmes, each
designed to tone a specific muscle group.
EMS 1 Abdominal muscles
EMS 2 Thighs / waist
EMS 3 Buttocks / arms
For further information on what areas of the body,
you can tone with the Femme Elite, please call Body
Clock Health Care on 020 8532 9595 or visit
www.bodyclock.co.uk
14
Before first use of the Femme Elite, please
familiarise yourself with the warnings and
contraindications contained on page 4.

15
Using the Femme Elite in EMS Mode
To commence treatment carefully peel the
electrodes from the plastic backing, using your
forefinger and thumb. Place them on your body as
shown on diagrams below. The ‘black squares’
represent where to place the electrodes.
Once the electrodes are positioned correctly, switch
the unit on. ‘EMS’ should then appear on the screen.
f it does not switch the unit off and adjust the mode
selector to ‘EMS’. Then switch the unit on again.
You can then choose your programme using the
‘PROG key’. Select the programme suitable for the
muscle group you wish to tone. Gradually increase
the intensity, using the ‘ON/Up’ key, until the
tensing sensation is comfortable. The intensity
level appears as blocks on the bottom of the screen
(see page 5).
EMS Programme 1 -
Abdominal
EMS Programme 2 -
Thighs and Waist
EMS Programme 3 - Buttocks and Arms
Front Upper Arms Back Upper Arms Buttocks
Lower
Abdominal
Upper
Abdominal Waist nner & Upper
Thighs

EMS - Frequently Asked uestions
QIs it effective?
A EMS (Electrical Muscle Stimulation) is highly
effective for both cosmetic toning and medical
usage. However, for best results EMS should be
accompanied with a sensible exercise
programme so that muscles are correctly
worked.
QAre there any precautions I should take?
A Yes, revert to precaution on page 4.
QHow long will it take to see results?
A Results vary from woman to woman. Some
women may see results very quickly; for others it
may take several weeks.
QCan I use it after giving birth?
A You can do, but not until about 12 weeks after
the birth. Consult your health visitor if you wish
to use it before then.
QWhat is the difference between the EMS on the
Femme Elite and the muscles toners you can
buy on the high street?
A Technologically, there is much similarity.
However, the Femme Elite is manufactured to be
fully compliant with strict medical device
regulations, ensuring high quality. The Femme
Elite is also designed specially to tone the
muscles women generally wish to tone.
16

Technical Data
Equipment type Single Channel Digital TENS
Display Digital LCD
Output Waveform Bi-phasic rectangular
Auto Power - Off 5 Minutes
Programme Specifications
TENS 1 Freq. / Pulse Width : 80Hz / 125µs.
TENS 2 Freq. / Pulse Width : 2 Hz / 200µs.
TENS 3 Burst 2pps;
Freq. / Pulse Width : 80 Hz / 150µs.
TENS 4 (Dense Disperse)
3 secs @ 80Hz with 100µs.
3 secs @ 2 HZ with 200µs.
Programme Freq. P.W. On Time(s) Off Time(s) Ramp Ramp
(Hz) (µs) (Plus Ramp On(s) Off (s)
On)
EMS 1 50 125 431N/A
EMS 2 50 150 551N/A
EMS 3 30 200 N/A N/A 33
Programme Output Frequency / Duration
PELV 1
5Hz / 3mins
10Hz / 5mins
15Hz / 5mins
20Hz / 5mins
15Hz / 5mins
10Hz / 5mins
5Hz / 2mins
Total time = 30mins
PELV 2
10Hz / 5mins
35Hz / 5mins
50Hz / 10mins
35Hz / 5mins
10Hz / 5mins
Total time = 30mins
PELV 3
M XED
10Hz / 10mins
20Hz / 5mins
30Hz / 5mins
40Hz / 5mins
50Hz / 10mins
40Hz / 5mins
30Hz / 5mins
20Hz / 5mins
10Hz / 10mins
Total time = 60mins
17

18
Useful Contacts:
Body Clock Health Care Ltd
Suppliers of TENS and EMS units.
www.bodyclock.co.uk
020 8532 9595
Babycare TENS
Leading suppliers of TENS machines for labour
and beyond.
www.babycaretens.co.uk
0845 230 9737
The Continence Foundation
Confidential nformation and advice about bladder
problems from specialist nurses.
www.continence-foundation.org.uk
0845 345 0165
Promocon
ndependent and impartial information on
continence products and services.
www.promocon2001.co.uk
0161 834 2001
Incontact
National charity for people affected by bladder and
bowel problems.
www.incontact.org
0870 770 3246

19

Body Clock Health Care Ltd
108 George Lane, South Woodford,
London E18 1AD
Tel (+44) (0)20 8532 9595
Fax (+44) (0)20 8532 9551
www.bodyclock.co.uk
e-mail customercar[email protected].uk
0120
January 2010
ISO 9001:2008 ISO 13485:2003
EC DIRECTIVE 93/42/EEC Annex V