TensCare Kegel Toner User manual

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QUICKSTART GUIDE
For the full version instructions for use, visit:
www.tenscare.co.uk/continence/kegel-toner
Clean the probe with an
alcohol-free anti-bacterial wipe
or with warm soapy water
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2
3
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ON
Button P
Connect the unit with the vaginal
probe and insert the probe
Press and hold the ON button
to switch the device on
Select the programme by
pressing the button P
Regulate the output intensity
with the buttons ▲ and ▼
Press and hold the OFF button
to switch the device off
UP
DOWN
OFF

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CONTENTS
1. INTRODUCTION.............................................................5
2. INDICATIONS FOR USE ................................................5
3. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS
.........................................................................................6
4. PROGRAMMEMES.......................................................10
4.1. PROGRAMMEME SETTINGS ..........................10
4.2. PRESET PROGRAMMES.................................10
5. CONTENT .....................................................................11
6. UNIT INFORMATION....................................................12
6.1. CONTROLS & DISPLAY ...................................12
6.2. OPERATING INSTRUCTIONS .........................12
7. SETTING UP AND USING THE KEGEL TONER ........ 16
7.1. INSTALLATION OF BATTERIES ......................16
7.2. CONNECTING LEAD WIRE.............................. 17
7.3. PREPARING FOR SESSION............................17
7.4. TRAINING SESSION......................................... 18
7.5. AFTER YOUR TRAINING SESSION ................19
8. CLEANING ....................................................................20
9. DISPOSAL OF WASTE ELECTRICAL AND
ELECTRONIC PRODUCTS ..................................................... 20
10. ACCESSORIES ............................................................21
11. TROUBLESHOOTING ..................................................21
12. GENERAL SPECIFICATION ........................................24
13. EMC...............................................................................26

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SYMBOLS USED
TYPE BF APPLIED PART: 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.
Atmospheric Pressure: indicates the atmospheric
limits to which the medical device can be safely
exposed.
Manufacturer Symbol
Date of Manufacture: indicates the date which the
medical device was manufactured. This is included
within the serial number found on the device (usually
on the back of the device), either as “E/Year/Number”
(YY/123456) or “E/Month/Year/Number”
(MM/YY/123456).
Medical Device
This medical device is indicated for home use.
CE Mark
Importer Symbol

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This medical device is not water resistant and should
be protected from liquids.
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.
1. INTRODUCTION
Device Description & Principles of Design
The Kegel Toner is a powered muscle stimulator used for
strengthening the pelvic floor muscles.
The Kegel Toner is very easy to use, with two preset training
programmes, two choices of exercise time and simple push
button control.
2. INDICATIONS FOR USE
The Kegel Toner is intended to provide electrical
stimulation and neuromuscular re-education for the
purpose of rehabilitation of weak pelvic floor muscles
for the treatment of stress incontinence in women.
The Kegel Toner is intended for adult women suffering from the
involuntary loss of urine when coughing, laughing, sneezing or
exercising (known as stress urinary 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.
Kegel Toner is not recommended if you ONLY have symptoms
of urinary frequency or urgency (using the restroom very

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frequently or having to rush to the restroom) and have NO
symptoms of leakage when coughing, laughing, sneezing or
exercising.
Warning: Not suitable for use in children without
medical supervision.
3. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS
In this manual:
A Contraindication is used when a device should not
be used because the risk of use clearly outweighs any
foreseeable benefits and may result in serious injury or
death.
A Warning is used when failure to follow the
instructions may result in serious injury or death.
A Caution is used when failure to follow the instructions
may result in a minor or moderate injury, or damage to
the device or other property.
Notes are used to provide clarification or
recommendation.
CONTRAINDICATIONS:
•Do not use if you are pregnant
•Do not use if you are attempting to become pregnant
•Do not use if you have a cardiac demand pacemaker or
implanted defibrillator
•Do not use if you have symptoms of active urinary tract
infection, vaginal infections, or localized lesions
•Do not use if you have a diagnosis of extra-urethral or
overflow incontinence
•Do not use if you have severe urine retention
•Do not use if you have poor sensation in the pelvic region
•Do not use if you have cognitive disabilities, i.e.; Alzheimer’s
disease or dementia
•Do not use if you are unable to properly insert the Trainer
•Do not use if you have active pelvic cancer
•Do not use if you have an intestinal clamp

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•You must be 6 weeks post pelvic surgery or vaginal childbirth
to use this device
•Do not use this device for diagnostic purposes or critical
patient monitoring
•This device is not (external) defibrillator-proof
WARNINGS:
Warning: The Kegel Trainer is intended for single patient use
only. Do not share your Kegel Trainer with anyone else.
Improper treatment or cross-infection may occur.
Warning: The device should not be used while walking, driving,
operating machinery, or any other activity in which involuntary
muscle contraction may put you at risk of injury.
Warning: If you have active cancer, consult with your clinician
before use due to concerns for stimulation potentially spreading
cancerous cells.
Warning: Caution should be used if you have suspected or
diagnosed heart problems because stimulation devices can
affect heart rhythm in certain circumstances.
Warning: Caution should be used if you have suspected or
diagnosed epilepsy as unexpected seizures may impair usage.
Warning: Caution should be used if you have a bleeding disorder
as stimulation increases blood flow to the stimulated region.
Warning: Do NOT use Kegel Toner while simultaneously
connected to high frequency surgical equipment as it may result
in burns at the site of stimulator electrodes and possible damage
to the stimulator.
Warning: Do NOT use in close proximity (e.g. 1 m) to a
shortwave or microwave as this may produce instability in the
stimulator output.
CAUTIONS:
Caution: Read all instructions before use. Failure to follow
these directions may result in personal injury or damage to the
equipment.
Caution: Do not use a Kegel Toner device that appears to be
damaged. Using a damaged device may result in personal injury.

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Caution: If tissue irritation occurs, discontinue treatment
immediately. Ask your care provider for advice before
continuing further treatment to prevent injury.
Caution: Kegel Toner is intended for indoor use only because
it is an electronic device.
Caution: Only use recommended cleaning solutions that leave
no residue to prevent irritation or infection. Do not soak as this
could damage the device.
Caution: It is important that the Trainer is cleaned after each
use. Ineffective cleaning may lead to irritation or infection.
Caution: Never insert or remove Kegel Trainer unless the
control unit is powered OFF as insertion or removal when
stimulation is active may cause discomfort or tissue irritation.
Caution: Do not use a silicone-based lubricant on the
stimulation contacts as it may decrease the effectiveness of
Kegel Toner’s muscle stimulation.
Caution: Caution should be used if you have total/partial
prolapse of the uterus/vagina.
Caution: The long-term effects of chronic muscle stimulation
are unknown.
Caution: Skin irritation and burns beneath stimulation contacts
have been reported with the use of powered stimulators.
Caution: Do not use the device in water because it is an
electronic device and use in water may cause patient injury.
Caution: Do not operate device within 10 feet of operating
televisions, arc welders, radio thermal treatment equipment, X-
ray machines, MRI machines, or any other equipment that
produces magnetic fields, sparks, or radio transmissions, RF
communication equipment can affect this device.
Caution: The stainless steel in the Trainer electrodes contains
some Nickel. This could cause a reaction if you have a Nickel
allergy.
KEGEL TRAINER CAUTIONS:
Caution: The Kegel Trainer is intended for single patient use
only. Do not share your Kegel Trainer with anyone else.
Improper treatment or cross-infection may occur.

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Caution: It is important that the Kegel Trainer is cleaned after
each use. Ineffective cleaning may lead to irritation or infection.
Caution: Never insert or remove Kegel Trainer unless the
control unit is powered OFF as insertion or removal when
stimulation is active may cause discomfort or tissue irritation.
Caution: If tissue irritation occurs, discontinue treatment
immediately. Ask your healthcare professional for advice before
continuing further treatment to prevent injury.
Caution: Do not use a silicone-based lubricant on the metal
plates of the Kegel Trainer as it may decrease the effectiveness
of Kegel Toner’s muscle stimulation.
Caution: The stainless steel in the Kegel Trainer’s metal plates
contain some Nickel. This could cause a reaction if you have a
Nickel allergy.
Caution: Do not use this device with Kegel Trainer other than
those recommended by the manufacturer in section 10.
Electrodes with smaller surface area may cause tissue irritation.
TO KEEP YOUR DEVICE IN GOOD WORKING ORDER,
OBSERVE THE FOLLOWING ADDITIONAL CAUTIONS:
Caution Not intended for use in an oxygen rich environment .
Caution Not intended for use in conjunction with flammable
anaesthetics or flammable agents.
Caution The patient is an intended operator.
Caution Do not service and maintain the device while in use.
Caution Maintenance and all repairs should only be carried out
by an authorized agency. The manufacturer will not be held
responsible for the results of maintenance or repairs by
unauthorized persons.
If necessary, we will provide circuit diagrams, component part
lists or other information that will assist authorized service
personnel to repair the device.
Caution The operator should not touch the patient at the same
time when touching the battery output.
Caution: There are no user serviceable parts. No modification of
this equipment is allowed.
Caution Keep away from pets and pests
Caution: should be observed when using the Kegel Toner at
high strength settings. Kegel Toner has a Yellow LED light on

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output socket which means the output will exceed 10 mA (R.M.S)
or 10 V (R.M.S) averaged over any period of 1 sec. Prolonged
use at high settings may cause muscle injury or tissue
inflammation.
Do not use this device with a leadwire or Trainer other than
those recommended by the manufacturer in section 10.
Do not immerse your unit or Trainer in water or place it close to
excessive heat as this may cause it to cease to operate correctly.
Do not attempt to open up the unit. This may affect the correct
operation of the unit and will invalidate the guarantee.
Do notmix old, new or different types of batteries as this may
lead to battery leakage or low battery indication.
Caution:Temperature & Relative Humidity of storage: -10°C to
+60°C, 15 to 75% R.H. Temperature & Relative Humidity of
transportation: -10°C to +60°C, 15 to 75% R.H.
4. PROGRAMMEMES
4.1. PROGRAMMEME SETTINGS
4.2. PRESET PROGRAMMES
The Kegel Toner has two preset programmes. One to treat
stress incontinence (TRAIN) and one aftercare programme to
tone the pelvic floor muscles (TONE).
Programme TRAIN TONE
Freq. (Hz) 50 35
Pulse width (μs) 300 250
Ramp Up & Down (s) 1 2
Plateau (s) 5 3
Rest (s) 10 6
Default duration (min) 20 20

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STRESS INCONTINENCE:
Shown on the screen as: TRAIN
The TRAIN programme strengthens the muscles of the pelvic
floor using gentle stimulation. Once these muscles are stronger
they are better able to resist urinary leakage caused by external
pressure being applied to the bladder such as with a cough,
sneeze or physical exertion.
The stimulation causes the muscles to contract and work. This
builds their strength.
Like any exercise this takes time to show results. Successful
treatment requires use once a day for one to three months. You
may notice an improvement after about four weeks. It helps to
keep a diary of leakage problems so that you can measure this
improvement.
AFTERCARE:
Shown on the screen as: TONE
Having restored your pelvic floor muscles to an excellent
condition you will want to keep them toned and strong. Regular
use of this programme, about twice a week, will ensure that your
muscles remains fit and toned.
The TONE programme may also be used as an alternative
treatment for TRAIN.
5. CONTENT
The pack contains:
•1 x Kegel Toner continence stimulator unit
•1 x Lead wire (L-CPT)
•1 x Liberty Kegel Trainer (X-VPK)
•2 x AA 1.5V alkaline batteries
•1 x Storage pouch

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6. UNIT INFORMATION
6.1. CONTROLS & DISPLAY
6.2. OPERATING INSTRUCTIONS
ON/OFF
To turn the unit on, press the ON button and hold for
3 to 5 seconds until the display shows.
To turn the unit off, press ▼ button to remove keypad
lock and press the OFF button and hold for 3 to 5
seconds until the display stops.
At first use, or after changing batteries, the display shows that
the unit is automatically set in programme TRAIN at zero
strength.
ON
OFF

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When switched on the unit will automatically start in the
programme which was being used when it was last switched off.
When switched on the unit will automatically start in the
programme which was being used when it was last switched off.
During start up to stop the increase in strength at any time, press
any key once.
The unit will turn off automatically:
•When the Timer reaches zero,
•If it is left at zero strength for more than 5 minutes.
Note: Always check unit is OFF before applying or
removing Kegel Trainer.
The backlight will turn off 10 seconds after the last button press.
STRENGTH CONTROLS
The buttons marked ▲ and ▼ are the strength
controls. To increase strength, press and hold down
the button ▲until required strength is achieved. To
decrease the strength, press and release the button
▼. To increase strength in steps of 1 mA, press and
release the button ▲.
The unit will remain in the WORK part of the cycle for 5 seconds
while intensity is being adjusted.
The strength levels are shown on the LCD.
The strength control buttons will not operate until the unit is
properly connected to you (Kegel Trainer inserted
correctly). Kegel Toner detects a disconnection and
automatically returns the strength to zero.
The unit has 99 levels of strength. If you hold down the button ▲
for 3 to 5 seconds, the strength will start scrolling.
You may feel nothing over the first few presses. Continue
pressing until the sensation is strong but comfortable. Further
increases during use may be necessary if your body becomes
used to the sensation.
▲
▼

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The yellow LED on the output socket indicates that there is an
active output. The display will remain on for 5 seconds after the
plug is removed.
PROGRAMME CONTROL
The button marked Pis the programme control. The
Kegel Toner has two preset programmes. At first
use, the unit automatically goes to programme
TRAIN. Next time it is switched on, it will default to the
programme used last.
Each time you press and release the Pbutton, the programme
changes and is shown on the LCD.
Each time you change the programme, the strength level reverts
back to zero. This is a safety feature to alleviate any sudden
feeling of a surge, as each programme gives a different
sensation.
The LOCK BUTTON can be used to lock all controls
except for the strength down ▼ and OFF buttons. To
activate, press and hold down the Pbutton for at
least 5 seconds until the lock icon is displayed on the screen. To
deactivate, press and hold down the Pbutton for at least 5
seconds until the lock icon is no longer displayed on the screen
and is replaced by the programmeyou are using.
TREATMENT TIMER
Each time you switch on the Kegel Toner the length
of time of your programme will automatically revert
to 20 minutes.
During use the unit counts down the minutes which are shown
on the screen. On reaching zero the unit will switch off.
By pressing and releasing the Tbutton you can manually
override and select a shorter treatment time of 10 minutes. You
may wish to use this during your early training sessions.
The length of time that you have selected will be shown on the
screen. The minutes will start to count down once you start the
programme.
If you hold down this key for 5 seconds, you can PAUSE the
timer, allowing you to interrupt the treatment session, and
P
T

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resume it later. Press and release the Tbutton to resume the
session.
Return to main screen by pressing any other key.
LOW BATTERY
An empty battery symbol will show when you need
to change the batteries. The unit will shut down
about 2 minutes after this.
LEADS ALARM
The Kegel Toner monitors the connection and the contact
between you and the Kegel Trainer probe. This is to prevent
sudden changes if a broken connection is re-made. If either of
these goes outside of a standard range while the strength is
above 20, the unit will flash LEADS, bleep three times, and return
the strength to 0.
Check the lead and if necessary, lubricate the Kegel Trainer with
a water-based lubricant. Please see section 11 for more
troubleshooting tips.
MEMORY
The Kegel Toner has a Memory with three functions:
1) Programme Retention. When you switch the unit on, it will
automatically start in the programme which was being used when
it was switched off.
2) Usage. Press Tand ▼together and hold down for 3 to 5
seconds. The display will show the number of times the unit has
been used and the duration of use in hours.
Press the same buttons again to return to normal controls.
3) Memory Reset. To reset memory to zero, hold down the Tand
OFF buttons together for 3 to 5 seconds.
Number of uses
Time used in hours

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7. SETTING UP AND USING THE KEGEL TONER
7.1. INSTALLATION OF BATTERIES
1) Remove battery cover by pulling on tag.
2) Insert batteries.
Ensure that the batteries are inserted the right way as shown in
battery compartment and that the ribbon is behind them.
3) Replace battery cover.
Battery Life
Batteries should last at least 15 hours at 50 mA, 300 μs, 50 Hz.
Unused batteries have a nominal shelf life of 3 year, but will
usually last longer than this.
Battery Warnings
Do NOT pierce, open, disassemble, or use in a humid and/or
corrosive environment.
Do NOT expose to temperatures over 60°C(140F).
Do NOT put, store or leave near sources of heat, in direct strong
sunlight, in a high temperature location, in a pressurized
container or in a microwave oven.
Do NOT immerse in water or sea water, or get wet.
Do NOT short-circuit.
Do NOT connect the device unless the battery cover is in place.
If battery leakage occurs and comes in contact with the skin or
eyes, wash thoroughly with lots of water and immediately seek
medical attention.
Warning: Keep batteries out of the reach of children to prevent
them from swallowing them by mistake. If swallowed by child,
contact doctor immediately.
Caution NEVER attempt to recharge an alkaline
battery. Risk of explosion.
Caution Do not mix old, new or different types of
batteries as this may lead to battery leakage or low
battery indication.

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Disposal: Always dispose of batteries and device responsibly
according to local government guidelines. Do not throw batteries
onto a fire. Risk of explosion.
7.2. CONNECTING LEAD WIRE
Insert the lead wire plug into the base of the unit.
Connect the lead from the base of the unit to the lead in the
Kegel Trainer. Push the pin ends firmly into the pigtail ends of
the Kegel Trainer lead.
The lead wires may be damaged by rough handling and should
be treated with care.
7.3. PREPARING FOR SESSION
1) Before using Kegel Toner, you will need to visit the toilet.
2) Lubricate the metal electrode surfaces and Kegel Trainer tip
with a water-based lubricant, such as TensCare Go Gel or
water.
3) Choose a comfortable position, such as lying down on your
bed on your side with your knees raised.
Warning: Ensure the Kegel Toner is switched OFF
before inserting the Kegel Trainer.
4) After wires are securely connected, insert the Kegel Trainer
into the vagina, in the same way as a tampon, with the two
silver plates side to side: one plate on left and the other on the
right, until only the flange at the end is visible. The Kegel
Trainer will naturally position itself with the widest part of the
flange vertically.
5) The metal parts conduct the electrical pulse and should be in
contact with the main part of the muscle at all times. The
tissues close to the entrance are more sensitive, so you
should avoid stimulating them.
Note: The flange should not be inserted into the vagina
and should remain outside of the vagina at all times.

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7.4. TRAINING SESSION
1) Press and hold the ON button on the control unit for 3 to 5
seconds to switch the control unit on.
2) You can select from the two preset programmes (see section
4). To change between the programmes, press the
programme selector, which is labelled P.
3) With the required programme selected, you can adjust the
intensity of the muscle stimulation until you reach a
comfortable level. Once you have reached a comfortable level,
5 seconds after you stop pressing the button, the intermittent
work/rest phase will start. The machine will take itself to 0 mA
for a rest period and then take itself back up to the level of
intensity you chose, to work the muscle. This cycle will
continue for the 20 minutes of the programme.
Note: The strength required varies widely between
users - some will use the Kegel Toner at full power –
99 mA. The Kegel Toner strength will go up at 1 mA
increments.
Initially the sensation through the Kegel Trainer may be limited
but will improve during treatment. Take care not to use too much
strength and thereby over stimulate the muscles until normal
sensation is restored. The sensation may not be even as it may
vary depending on the sensitivity of the nerves.
The LCD display shows the strength of intensity used. The aim
is to increase this over a few days. But remember there is no
hurry, so only increase the strength of the stimulation as and
when you are comfortable and ready to progress.
Note: If the sensation becomes uncomfortable, reduce
the intensity using the button ▼.
When switched on, in TRAIN and TONE programmes the unit
will go through an exercise programme for 3-5 seconds, followed
by a rest period of 6-10 seconds. The Kegel Toner causes a
sensation which feels like a strong drawing in of the vagina and
pulling up of the pelvic floor. The natural reaction will be to pull in
and up with the muscles.

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At lower strength settings, you may not feel any sensation at all,
this depends very much on the individual and any pre-existing
physical conditions, so slowly increase the intensity by
repeatedly pressing the ▲ button until you begin to feel the
muscles around your vagina contract.
For best results in these programmes try to contract the pelvic
floor muscles along with the Kegel Toner, and to sustain the
contraction into the rest interval. If possible, link the contraction
to your breathing to get into a gentle rhythm.
Increase the strength as high as it is comfortable, and then take
it back down one step. The strength display on the control unit
will reduce to 0 and flash during the rest period.
The length of each session is automatically set to 20 minutes.
The length of each session for muscle strengthening will also
depend on your ability to contract and your resistance to fatigue.
Be careful not to overuse early on, as the resulting aches may
not be felt until the next day.
Note: If you experience cramping, switch the unit off
until the symptoms go away then continue the session
with the intensity set at a lower level.
7.5. AFTER YOUR TRAINING SESSION
When the timer reaches zero, your session is complete, and the
unit turns off.
1) Check that the control unit is off. If it is not, hold down the OFF
button to switch off then remove the Kegel Trainer from your
vagina by holding the positioning end rim and gently pulling
outwards.
If you are using the pointer, detach this first before removing
the Kegel Trainer.
2) Wash and thoroughly dry the Kegel Trainer and return it to
the storage pouch.
3) The Kegel Toner will not only improve your pelvic floor
muscles but also help you to recognise the correct sensation
you need to feel when doing your Kegel exercises.
Note: When removing the Kegel Trainer, DO NOT
PULL ON THE LEAD WIRE.