Body Clock SensaTONE User manual

SensaTONE
Instructions for use
TM
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The SensaTONE from Body Clock
is an ultra simple, yet powerful
digital Pelvic Floor Stimulator
(PFS). This compact, stylish unit
has been designed for use by
women of all ages to help
strengthen pelvic floor muscles
and to treat incontinence.
ike 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 suffers from some form of
incontinence during her life. It can occur at any
time, most commonly after childbirth. The severity
of incontinence can vary.
Before you use the SensaTONE, 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 nit
Equipment providing a particular
degree of protection against electric
shock particularly regarding allowable
leakage currents having a BF type
(floating) applied part.
Warning – refer to accompanying
documents i.e. these instructions.
Denotes a product which must be
disposed of safely.
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Contents
Precautions and Contraindications .................. 4
Controls on the SensaTONE .............................. 5
Display Symbols and Their Meanings................ 5
Additional Functions ........................................ 5
Setting up Your SensaTONE ............................ 6
Useful Diagrams .............................................. 7
Using Your SensaTONE for PFS.......................... 8
Choosing the Right PFS Mode .......................... 9
Frequency of Use .............................................. 9
Using Mode D – After Care ................................ 9
PFS FAQ’s ........................................................ 10
Technical Specification .................................... 11
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Precautions and Contraindications
1. Do NOT use the SensaTONE 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. The SensaTONE can NOT be used during pregnancy.
You can use it from 12 weeks after the birth.
4. Do NOT use the SensaTONE if you suffering from any
urinary or vaginal infection.
5. Do NOT use the SensaTONE at the same time as
a barrier contraceptive device such as a diaphragm
or cervical cap.
6. Never use the SensaTONE to mask undiagnosed
pain since this could require urgent treatment.
7. The SensaTONE should NOT be used during the
menstrual period.
If you have any concerns regarding use of the SensaTONE
please do not hesitate to contact Body Clock Health Care
on (+44) (0)20 8532 9595.
General Precautions
1. Do NOT use this unit without first reading these
instructions.
2. Do NOT immerse the SensaTONE in any liquid.
3. Do NOT place it close to any source of excessive heat
or operate it in the presence of flammable gas.
4. Do NOT drop this unit onto a hard surface.
5. Do NOT attempt to dismantle the SensaTONE.
7. Only use specified batteries and electrodes.
8. If damaged, do not use. Return to supplier.
9. Remove the batteries when not in use.
10. Do NOT use while driving or operating potentially
dangerous machinery or while using a microwave.
11. Keep out of the reach of children.
12. Do NOT place the vaginal probe near the eyes, in the
mouth, over the front or sides of the neck, across the
head, heart.
13. Do NOT use in the presence of tuberculosis,
malignant tumours, very high or very low blood
pressure, high fever or acute inflammatory disease
unless under medical supervision.
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5
Controls on the SensaTONE
POWER Key – Turns the SensaTONE on and off.
ser Display – Indicates the mode in use and
the intensity level (also see diagram below).
Mode Key – Switch between programmes
A, B, C and D.
Intensity p – Increases the intensity of
the pulses.
Intensity Down – Decreases the intensity of the
pulses.
ser Display
Additional Functions
Load Detector – If the vaginal probe becomes
detached, the intensity will drop back to zero.
Low Battery Indicator – A flashing battery symbol
will be shown on the display.
Automatic Power Off – When the unit intensity
levels are zero, and the SensaTONE has not been
in use for about 5 minutes, the unit will shut off
automatically.





Indicates the
mode in use.
Indicates the
intensity level
of the pulses.
ow battery
indicator.
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Setting up Your SensaTONE
Check you have the following contents:
• 1 x SensaTONE unit
• 1 x SensaTONE vaginal probe
• 1 x eadwire
• 1 x ubricant gel sachet
• 2 x AAA batteries
• 1 x Carrying pouch
• 1 x Neck cord
The Assembly Stage
1. Slide open the battery cover on the back of the
unit to expose the battery compartment.
2. Insert the batteries according to the diagram
found in the battery compartment. Replace the
cover.
3. Remove the SensaTONE vaginal probe from its
packaging.
4. Wash hands in soap and warm running water.
iberally wash the probe using the same
method but do not soak. Rinse all soap and
residue from hands and probe. Dry the probe
with a clean cloth/paper towel and allow to air
dry.
5. Ensure that the SensaTONE is switched off.
6. Insert the end of the leadwire into the socket at
the bottom of the SensaTONE. Connect the
other end of the leadwire to the probe.
See diagram (i) on page 7.
7. Apply a thin coating of lubricating gel to
the probe.
8. Insert the probe until the flange at the base of
the probe is sited between the labia. There is no
need for precise orientation. See diagram (ii) on
page 7.
9. You are now ready to begin stimulation.
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Important
• The SensaTONE vaginal probe is single
patient use ONLY. Additional probes can be
purchased from Body Clock.
• It may be re-used by the same patient.
• Wash as instructed before each use.
• Do NOT use if the pack is open or damaged.
7
pelvic floor muscle
urethra
vagina
anus
Diagram (i)
Diagram (ii)
probe
seful Diagrams
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8
sing Your SensaTONE for PFS
PFS - Pelvic Floor Stimulation
a) Switch the unit on by pressing the Power Key
button. The SensaTONE will always start up in
Mode A.
b) The SensaTONE has four preset programmes:
Mode A - Urge Incontinence
Mode B - Stress Incontinence
Mode C - Mixed Incontinence
Mode D - After Care
c) Select the mode most appropriate for your type
of incontinence by pressing the ‘MODE’ key.
Please refer to page 9 if you are unsure of which
mode to use.
d) Now begin by pressing the ‘intensity up’ key.
Each time you press this key, you will see the
intensity level increase on the CD.
e) Gradually increase the ‘intensity up’ key until you
comfortably feel your muscles contracting. If the
sensation feels too strong, simply press the
‘intensity down’ key minimise the feeling.
f) Modes A, B and C all have fixed programme
times. The SensaTONE will automatically switch
off once the programme is complete. Mode D
does not have a fixed programme time. Refer to
page 9 for more information about Mode D.
g) After use, always remember to ensure that the
SensaTONE is switched off. Remove the
SensaTONE probe from your body, disconnect
the leads and then clean it in accordance with the
above instructions found on page 6 or in the
SensaTONE probe instruction manual.
The SensaTONE should NOT be used:
• During pregnancy
• During the menstrual period
• If you suffer a urinary or vaginal infection
• At the same time as a barrier contraceptive
device such as a diaphragm or cervical cap
Before first use of the SensaTONE, please
familiarise yourself with the ‘Precautions and
Contraindications’ contained on page 4.
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99
Choosing the Right PFS Mode
There are three types of incontinence, all of which
can be treated with the SensaTONE:
1. rge incontinence (MODE A) - occurs with a
strong, sudden and uncontrollable urge to urinate.
2. Stress incontinence (MODE B) - occurs when
sneezing, coughing, laughing, lifting or during
exercise and causes a small amount of urine to leak.
3. Mixed incontinence (MODE C) - a combination
of urge and stress incontinence.
Frequency of se
Below is a guide showing how often to use each
PFS mode on your SensaTONE. If your muscles
start to ache, or you have any problems using the
SensaTONE, please contact your medical adviser.
DO NOT EXCEED TREATMENT TIMES NLESS ADVISED BY
A MEDICAL PROFESSIONAL.
sing Mode D – After Care
This is an optional Mode and can be used as follows:
• Directly after treatment with the SensaTONE
provided you are not experiencing any muscle
fatigue.
• As a maintenance mode after you have been
using the sensatone on a regular basis and have
experienced an improvement in your condition.
Please note that there is no recommended
treatment time for this mode. It is at your
discretion. It is suggested that it is used no more
than between 15-30 minutes per day.
Programme
Mode A
Mode B
Mode C
Mode D
Length
30 mins
30 mins
45 mins
–
How often
1-2 times a day
Complete the
programme once a day
Once a day or every other
day depending on severity
Please see
‘Using Mode D’ below
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10
PFS - Frequently Asked Questions
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.
RGE 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.
QWhat does it feel like?
A All three PFS programmes feel slightly different.
In 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.
If you have any further questions on
incontinence or need some advice,
contact The Bladder and Bowel
Foundation on:
Nurse helpline: (+44) (0)845 345 0165
Counsellor helpline: (+44) (0)870 770 3246
e-mail: [email protected]
web: www.bladderandbowelfoundation.org
Registered Charity No. 1085095
Reg Charity 1085095
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11
Programme Display Output Frequency/Duration
5Hz / 3 mins; 10Hz / 5 mins;
15Hz / 5 mins; 20Hz / 5 mins;
15Hz / 5 mins; 10Hz / 5 mins;
5Hz / 2mins
Total time = 30 mins
Urge A
10Hz / 5 mins; 35Hz / 5 mins;
50Hz / 10mins; 35Hz / 5mins;
10Hz / 5mins
Total time = 30 mins
Stress B
10Hz / 5mins; 20Hz / 5 mins;
30Hz / 5 mins; 40Hz / 5mins;
50Hz / 5mins; 40Hz / 5mins;
30Hz / 5mins; 20Hz / 5mins;
10Hz / 5mins
Total time = 45 mins
Mixed C
Freq. Modulation
Frequency increases
from 2 Hz to 10 Hz in 4 secs.
and then back to 2Hz in
another 4 secs.
Total cycle = 8 secs
Total time = 45 mins
After Care D
All outputs have 200µs pulse width. For the Urge,
Stress and Mixed mode, the output pulses are
alternatively switched on and off for 5 seconds.
Specifications
Output Channel Single Channel
Output Waveform Bi-phasic rectangular
Output Voltage 0-40V adjustable in 14 steps
across a 500 ohm load
Output Intensity 0-80mA adjustable in 14
steps across a 500 ohm load
Automatic 5 minutes
Power Off
Battery 2 x 1.5v AAA Batteries
Battery Low Detect 2.2V±0.1V
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Body Clock Health Care Ltd
108 George ane, South Woodford
ondon E18 1AD
Tel (+44) (0)20 8532 9595
Fax (+44) (0)20 8532 9551
www.bodyclock.co.uk
e-mail [email protected].uk
0120
July 2010 (2)
ISO 9001:2008 ISO 13485:2003
EC DIRECTIVE 93/42/EEC Annex V
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