Body Clock Health Care SensaTONE User manual

11
9
0120
arch 2017 (6)
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 [e-mail]
This manual is recyclable
SensaTONE
Instructions for use
Using Your Sensa ONE
For PFS
PFS - Pelvic Floor Stimulation
a) Switch the unit on by pressing
the Power Key button. The
SensaTONE will always start up
in ode A.
b) The SensaTONE has four
preset programmes:
Mode A - Urge Incontinence
Mode B - Stress Incontinence
Mode C - ixed Incontinence
Mode D - After Care
c) Select the mode most
appropriate for your type of
incontinence by pressing the
‘ ODE’ 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 LCD.
e) Carefully continue to press
‘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) odes A, B and C all have fixed
programme times. The
SensaTONE will automatically
switch off once the programme
is complete. ode D does not
have a fixed programme time.
Refer to page 9 for more
information about ode D.
g) After use, always remember to
ensure that the SensaTONE is
switched off. Then remove the
SensaTONE probe from your
body, disconnect the leads and
then clean it in accordance with
the instructions found on page
6 or in the SensaTONE probe
instruction manual.
8
Choosing he Right
PFS Mode
There are three types of
incontinence, all of which can be
treated with the SensaTONE:
1. Urge 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 Use
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.
Using 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.
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.
S RESS 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.
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.
Before first use of the
SensaTONE, please
familiarise yourself
with the ‘Precautions
and Contraindications’
contained on page 4.
The SensaTONE should
NO 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.
• Until 12 weeks after childbirth.
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 ode D’ above
DO NO EXCEED REA MEN IMES UNLESS ADVISED BY A MEDICAL PROFESSIONAL.
If you have any further
questions on
incontinence or need
some advice, contact
The Bladder and Bowel
Foundation on:
Helpline: (+44) (0)845 345 0165
e-mail:
[e-mail]
web:
www.bladderandbowelfoundation.org
Reg Charity
1085095
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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
otal time = 30 mins
Urge A
10Hz / 5 mins 35Hz / 5 mins 50Hz / 10mins
35Hz / 5mins 10Hz / 5mins
otal 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
otal time = 45 mins
ixed C
Frequency Modulation
Frequency increases from 2 Hz to 10 Hz in 4 secs.
and then back to 2Hz in another 4 secs.
otal cycle = 8 secs
otal time = 45 mins
After Care D
All outputs have 200µs pulse width. For the Urge, Stress and ixed 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 Power Off 5 minutes
Battery 2 x 1.5v AAA Batteries
Battery Low Detect 2.2V±0.1V
Guarantee
Your SensaTONE machine is guaranteed for a period of 2 years
against manufacturer’s defects. Please record purchase details
in the space provided below for your record purposes. The
guarantee does not include leads, electrodes, probes or battery.
Date of purchase:
Invoice number:

4
5 6 7
he Sensa ONE from
Body Clock is an ultra
simple, yet powerful
digital Pelvic Floor
Stimulator (PFS). his
compact, stylish unit
has been designed for
use by women of all
ages to help strengthen
pelvic floor muscles and
to treat incontinence.
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 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
of 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
particularly regarding
allowable leakage
currents having a BF
type (floating) applied
part.
Warning – refer to
accompanying
documents i.e.
these instructions.
Please keep device
away from sprays of
water or rain.
Denotes a product
which must be
disposed of safely.
This symbol indicates
the serial number
of the device and
includes the year
of manufacture.
The serial number can
be found in battery
compartment of this
device and also on the
outer packaging.
2 3
Contents
Precautions And Contraindications ...................................................... 4
Controls On The SensaTONE ................................................................ 5
Display Symbols And Their eanings .................................................. 5
Additional Functions ............................................................................ 5
Setting Up Your SensaTONE ................................................................ 6
Useful Diagrams .................................................................................. 7
Using Your SensaTONE For PFS ............................................................ 8
Choosing The Right PFS ode ............................................................ 9
Frequency Of Use .................................................................................. 9
Using ode D – After Care .................................................................... 9
PFS FAQ’s ............................................................................................ 10
Technical Specification ........................................................................ 11
Precautions And
Contraindications
1. Do NO 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 NO be used
during pregnancy. You can use it
from 12 weeks after the birth.
4. Do NO use the SensaTONE if you
suffering from any urinary or
vaginal infection.
5. Do NO use the SensaTONE at the
same time as a barrier
contraceptive device such as a
diaphragm, cervical cap or coil
without first checking with the
manufacturer of the coil to
establish that the two devices are
safe to use together.
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.
8. Remove the vaginal probe after
treatment.
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 NO use this unit without first
reading these instructions.
2. Do NOT handle or insert probe
unless the unit is switched off.
3. Do NO immerse unit in liquid.
4. Do NO place it close to any source
of excessive heat or operate it in
the presence of flammable gas.
5. Do NO drop this unit onto a hard
surface.
6. Do NO attempt to dismantle the
SensaTONE.
7. Only use specified batteries and
electrodes.
8. If damaged, do not use. Return to
supplier.
9. Remove batteries when not in use.
10. Do NO use while driving or
operating potentially dangerous
machinery or while using a
microwave.
11. Keep out of the reach of children.
12. Do NO place the vaginal probe
near the eyes, in the mouth, over
the front or sides of the neck,
across the head, heart.
13. Do NO use in the presence
of tuberculosis, malignant
tumours, very high or low blood
pressure, high fever or acute
inflammatory disease unless under
medical supervision
14. Do not use this device on infants or
people not capable of expressing
their intentions.
Controls On he Sensa ONE
Power Key – Turns the SensaTONE on
and off.
User 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 Up – Increases the intensity
of the pulses.
Intensity Down – Decreases the
intensity of the pulses.
User 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.
Low battery
indicator.





Setting Up Your
Sensa ONE
Check you have the following
contents:
• 1 x SensaTONE unit
• 1 x SensaTONE vaginal
probe
• 1 x Leadwire
• 1 x Lubricant gel sachet
• 1 x Neck cord
• 1 x Instructions
NB. batteries not included
he Assembly Stage
1. Ensure the SensaTONE unit
is switched off.
2. Slide open the battery cover
on the back of the unit
to expose the battery
compartment.
3. Insert the batteries matching
the + and – terminals,
according to the diagram
found in the battery
compartment. Replace the
cover.
4. Remove the SensaTONE
vaginal probe from its
packaging.
5. Wash hands in soap and warm
running water. Liberally wash
the probe using the same
method but do not soak. Rinse
all soap and residue from
hands and probe. Dry your
hands and the probe with a
clean cloth/paper towel and
allow to air dry.
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.
pelvic floor muscle
urethra
vagina
anus
Diagram (i)
Diagram (ii)
probe
Useful Diagrams
Important
• The SensaTONE vaginal probe is single patient use ONLY.
Additional probes and gel can only be purchased from Body Clock.
• Probes may be re-used by the same patient only.
• Wash probe as instructed before each use.
• Do NO use the probe if the pack is open or damaged.
This unit needs special precautions regarding E C and
needs to be installed and put into service according to
the E C information provided in the ACCO PANYING
DOCU ENT.
SN