Kegel8 Ultra 20 User manual

Operator’s manual
Ultra 20

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Symbols on the unit and case
Caution! (electrical output).
Follow operating instructions! Failure to do so could place
the patient or operator at risk.
Neuromuscular Stimulation (STIM) and EMG Triggered
Stimulation (ETS) should not be used by Patients tted with
demand style cardiac pacemakers. Please seek advice from
your health supervisor.
Patient’s shock protection type: BF (Body Floated) Equip-
ment. This equipment is not earthed but contains a battery
within an insulated unit.
Indicates the manufacturer’s catalogue number so that the
medical device can be identied.
Manufacturer's LOT/Batch number. Present it together
with SN number when you report a technical fault or
claim a warranty return.
Manufacturer's serial number of the unit. Present it
together with LOT number when you report a technical
fault or claim a warranty return.
Name and address of Manufacturer.
Date of manufacture.
Conformity indication with the essential health and
safety requirements set out in European Directives.
0088 - Notied Body identication (LRQA Ltd.)
This product should be kept dry.
IP20
on the unit
This is an indication for protection against ingress of water
and particulate matter. The mark IP20 on your unit means:
your unit is protected against solid foreign objects of 12.5mm
dia and greater. Not protected against water.
IP02
on the case
IP02 on the carrying case means: Protected from the ingress
of water droplets from a shower of rain.
Do not dispose in normal dustbin (see page 29 for the dis-
posal instructions).
REF

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Welcome to Kegel8® Ultra 20
Dear Customer,
Thank you for choosing Kegel8®Ultra 20. You are now one step
closer to having a stronger, healthier pelvic oor. Created especially
for women, the Kegel8® Ultra 20 is an e󰀨ective neuromuscular
stimulator (STIM). This means Kegel8® Ultra 20 works by producing
electrical pulses that stimulate the muscles and nerve bres in your
pelvic area.
Indications for use:
●pelvic pain
●back pain
●stress incontinence
●overactive bladder
●faecal incontinence
Also used for non medical purposes to:
●test pelvic sensitivity
●improve pelvic sensation
●exercise pelvic muscles
●maintanence pelvic oor
●pelvic sensitivity, strength and endurance
●improvement of local blood circulation
If you have never used a neuromuscular stimulator before, you
may be a little apprehensive. That’s quite normal - lots of people
are cautious at rst, but soon realise that there is nothing to worry
about. The probes are designed for comfort and while you will be
able to feel the e󰀨ects of the electric pulses, they should not cause
any discomfort. If you follow the instructions in this User Guide,
Kegel8® Ultra 20 is a safe and e󰀨ective way of exercising your
pelvic oor.
Customer Care We aim to provide our customers with
outstanding products and customer service. So if you have
comments or ideas regarding Kegel8®Ultra 20 features, please get
in touch (see Customer Service on page 61).

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Warnings
Please pay careful attention to the following safety warnings:
●Do not insert lead wires into a mains power supply.
●Do not immerse unit into water or any other substance.
●The unit is not protected from the ingress of water droplets from
a shower of rain if used outside the carrying case.
●Type BF equipment, Continuous Operation.
●Do not use the Kegel8®Ultra 20 unit in the presence of a
ammable anaesthetic gas mixture and air or with Oxygen or
Nitrous Oxide.
●If using rechargeable 9 Volt PP3 Nickel Metal Hydride batteries,
be sure to use a CE approved battery charger. Never connect
the Kegel8
®
Ultra 20 directly to a battery charger or to any
other mains powered equipment. We advise not to use Ni-Cad
rechargeable batteries.
●Patient Probes and Electrodes are for single patient use only.
●Keep out of reach of children.
●Do not use this stimulator on your facial area unless you are
under strict guidance from a qualied Clinician.
●Application of electrodes to the body between the neck and the
abdomen may increase abnormal heart rhythm (cardiac brillation)
●Operation in close proximity (e.g. 1m) to a shortwave or microwave
therapy equipment may produce instability in the stimulator output.
●Simultaneous connection of a patient to a high frequency
surgical equipment may result in burns at the site of the
stimulator electrodes and possible damage to the stimulator.
●It is recommended this unit be used following guidance of a
Physiotherapist Doctor or Continence Advisor.
●No modication of this equipment is allowed!

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Please read this Kegel8®Ultra 20 User Guide
before using this stimulation device.
STIM (Kegel8®Ultra 20) should not be used:
●By patients tted with a demand style cardiac pacemaker
unless so advised by their Doctor.
●During pregnancy [unless medically advised].
●By patients with undiagnosed pain conditions.
●By patients with undiagnosed skin, vaginal or rectal conditions.
●With patients who have diminished mental capacity or physical
competence who cannot handle the device properly.
●On anaesthetised or desensitised skin.
●When driving a vehicle or operating potentially dangerous
equipment.
When using Kegel8®Ultra 20:
●Use the Kegel8® Ultra 20 only as directed.
●Do not immerse the unit in water or any other liquid
●Keep unit out of reach of children.
●Seek professional advice if you are unsure about using Kegel8®
Ultra 20. Contact your distributor or healthcare professional.
●Only use CE approved electrode pads, vaginal and anal
probes.
Do not place electrodes:
●Over carotid sinus nerves, larynx or trachea.
●Inside the mouth.
●Over the area of the heart unless so advised by your doctor.
●On your facial area unless under strict guidance from a
qualied clinician.
●Do not apply stimulation across or through the head, directly
on the eyes, covering the mouth, on the front of the neck
(especially the carotid sinus) or via electrodes placed on the
chest and upper back or crossing over the heart.
Contra Indications & Precautions

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Contents
Symbols on the unit 2
Welcome to Kegel8® Ultra 20 3
Indications for Use 3
Warnings 4
Contra Indications & Precautions 5
Kegel8®Ultra 20 User Instructions 7
Important Safety Information 8
Kegel8®Ultra 20 Check List 10
Getting to Know Your Kegel8® Ultra 20 11
How Your Kegel8®Ultra 20 Works 16
What to Expect from Your Kegel8®Ultra20 17
Starting Your Kegel8®Ultra 20 Exercises 18
Inserting a Kegel8®Probe 23
Applying Kegel8® Ultra 20 Electrode Pads 24
Kegel8®Ultra 20 Exercise Tips 28
Choosing a Kegel8®Ultra 20 Programme 29
Sensitivity Tests (Probe Only) 30
Incontinence, Nocturia, and Overactive Bladder 32
Voluntary Exercises 36
Improve Sensation 37
Pain, Cramps, and Tightness 39
Pelvic Floor Health 41
Creating a Custom Programme 43
Taking Care of your Kegel8® 47
Frequently Asked Questions 49
Technical Specications 53
STIM Specications 54
Electromagnetic Compatibility and Interference (EMC) 55
Warranty 59
Clinical References 60

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Kegel8®Ultra 20
User Instructions

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Important Safety Information
Who Can Use Kegel8®Ultra 20 Pelvic Toner?
Your Kegel8® Ultra 20 is designed to be used by women and when
used correctly, is a safe and eective way of strengthening pelvic
oor muscles. However, as it works by using electrical pulses, there
are some people that should seek medical advice before using
Kegel8.
DO NOT USE:
●If you have been tted with a demand style cardiac pacemaker.
●During pregnancy.
●If you have undiagnosed pain, skin, vaginal or rectal conditions.
●On anaesthetised or desensitised skin.
●If you do not have the mental capacity or physical competence
to use the device as instructed.
●When driving a vehicle or operating potentially dangerous
equipment.
●In water or other uid. Never submerge your Kegel8 Ultra 20.
●While you are connected to high frequency equipment. Applying
the Kegel8 probes or electrodes while you are connected to
high frequency equipment could cause burns and damage your
Kegel8. If in doubt, please call your distributor for advice or
seek assistance from a doctor or healthcare professional.
Please note that Kegel8® Ultra 20 can be used safely by women
tted with IUD or Mirena coils. Kegel8 Ultra 20 does not a󰀨ect these
devices.
IMPORTANT
Only Use Your Kegel8®Ultra 20 as Described
in this User Guide.
Keep Out of Reach of Children.

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Where Can You Use your Kegel8®Ultra 20?
Kegel8® Ultra 20 is designed for home use, but can be used in
medical centres and hospitals too. Before you use your
Kegel8®Ultra 20, please make sure:
●The room does not contain ammable gases. This is especially
important in hospitals and medical centres as Kegel8 Ultra 20’s
electrical pulses can ignite ammable gases, such as those
used in anaesthetics. If in doubt, ask for assistance.
●You are not positioned close (1-2m) to a shortwave or
microwave therapy device, microwave oven, mobile telephone,
wireless device, or radio. These devices can cause instability in
your Kegel8 Ultra 20 unit.
Using your Kegel8®Ultra 20 Safely
●Only use Kegel8® Ultra 20 the in your vaginal and rectal regions
as described in this user guide. Never use Kegel8®Ultra 20 on
other parts of your body as the electrical pulses could damage
your health.
●To ensure your personal hygiene, do not allow other people to
use your probes. Always clean your probes thoroughly after use
(see Kegel8®Probe Care on page 47).
●Only use CE approved vaginal or rectal probes with your
Kegel8. All o󰀩cial Kegel8® probes are CE approved.
●To power your Kegel8® Ultra 20 device, use a 9v battery. Never
connect your Kegel8® Ultra 20 device or its probes to a mains
power supply as this could result in electrocution and death.
●Do not immerse your Kegel8® Ultra 20 device or its probes in
water, uids or any other substance.
●Please be aware that Kegel8®Ultra 20 is Type BF equipment
(provides some protection against electric shock).

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When you open the Kegel8® Ultra 20 packaging, you should nd:
●1 ×Kegel8®Ultra 20 unit.
●1 ×9 Volt Battery.
●1 or 2 ×Kegel8®Probe(s).
●1 or 2 x Kegel8® Lead Wire(s).
●1 x Kegel8® Ultra 20 User Guide.
●1 x Kegel8® Ultra 20 Product Guarantee Registration Form.
In the unlikely event that any of the items above are missing, please
contact Customer Service.
Kegel8®Ultra 20 Check List

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Getting to Know Your Kegel8® Ultra 20
Channel A Channel B
You will use Channel A and Channel B to connect your Kegel8®
Ultra 20 probe(s) to your Kegel8 Ultra 20 device. We recommend
that you connect a vaginal probe to Channel A. If you have an anal
probe, you can connect that to Channel B.
You will use the PRG button on the front when setting a programme
(see Choosing a Kegel8®Ultra 20 Programme on page 29) The
SET button on the front is only used when Creating a Custom
Programme (see page 43).
The front of the Kegel8 Ultra 20 also has two sets of + and -
buttons. You can use these buttons to increase (+) or decrease (-)
the strength of the electrical pulse being sent via Channel A and
Channel B respectively. (The buttons labelled Aare for Channel
A, those labelled B are for Channel B).
Front Back
LCD
Display
PRG
Battery
ON/
OFF
SET
Probe
Lock

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When you rst power up your Kegel8®Ultra 20, the LCD will display
the following information:
Hz
Hz amount is the number of electrical pulses per second (Hertz).
When you start using your Kegel8®Ultra 20, this value will vary,
depending on the programme you have selected.
µS
The µs amount is the duration of a single electrical pulse. The
higher the value, the more it penetrates your muscles. Again, this
amount will vary depending on the programme you have selected.
Current Phase
Beneath the µs amount is a series of ellipses (1-5). Each ellipse
represents a phase of your selected programme, and the current
phase is indicated by an arrow. As your programme progresses, the
arrow will move to show which phase is currently active.
0
mA
01P
0
MIN
2:
0
mA
150
Hz
3
µs
●Work
●Rest
●Alt
●Cont
●Mod

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Phase Mode
To the right of the LCD display are bullet points for 5 phase modes:
●Work - The ‘contract’ time. This is when your muscle will
tighten. Rest phases occur between Work phases.
●Rest - The ‘relax’ time between Work phases.
●Alt - Alternating control. This is not used by any of the built-
in programmes, but can be used for a custom programme. It
works by using both Channels alternately, so when Channel A
is ‘working’, Channel B is ‘resting’ and vice-versa.
●Cont - Continuous stimulation. The electrical current stimulates
your muscles for the entire Cont phase.
●Mod - Modulating. The electrical current is continuous during
this phase, but its intensity varies according to set limits.
A right-facing arrow, shown on the LCD, indicates which of the
modes are currently active. The phase modes that become
active when you use your Kegel8 Ultra 20 will vary depending on
the programme you choose (see Choosing a Kegel8®Ultra 20
Programme on page 29).
Programme Number and Programme Timer
The top-left area of the LCD shows the number of the programme
that is currently selected. Below the programme number is a time,
which indicates the amount of time remaining on the programme
(currently running).
When you start a programme, an additional time is shown on the
right of the LCD. This second time display shows the time of the
current phase.

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Channel Outputs (mA’s or MilliAmps)
The two large numbers at the bottom of the display show the
amount of electric current being output through Channel A and
Channel B. The large number on the left-hand side of the LCD
represents Channel A and the large number on the right-hand side
represents Channel B.
The Example (see page 15) shows how the electric current for the
channels is indicated on the LCD.
Battery Power Level
If your Kegel8 Ultra 20 battery is running low on power, a low battery
indicator appears on the LCD (above the Channel Outputs).
Lock
You can create a custom programme on your Kegel8 Ultra 20
and lock it in place. This prevents access to any of the other
programmes. If your Kegel8 Ultra 20 is locked to a specic
programme, a padlock icon is shown on the LCD.
Typically, the Lock function is used by medical professionals to
prevent patients from accessing other programmes. This is useful as
it means they can be sure patients only use the correct programme
for their condition.

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Your Kegel8 Probe(s)
Kegel8 Ultra 20 comes with 1 or 2 probes, depending on the version
of Ultra 20 you have bought. The vaginal probe is the primary probe
and you should connect it to Channel A. If you have a second probe
for anal use, you should connect it to Channel B.
If you have two probes, you can use
them separately or at the same time.
Each probe has a wire connected to
its ‘tail’ end and metal strips that run
up each side towards the ‘head’. The
electric pulse produced by your Kegel8
is transferred to your pelvic muscles
through the metal strips.
Example
If you connect your Kegel8 probe to Channel A, set the unit to run
programme 8, and press the + button for A, the LCD could show:
8
mA
08P
0
MIN
6:
0
mA
300
Hz
15
µs
●Work
●Rest
●Alt
●Cont
●Mod
45
MIN
Metal Strip
Metal Strip

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How Your Kegel8®Ultra 20 Works
The Kegel8® Ultra 20 Pelvic Health Device is one of a new breed
of modern Neuromuscular Stimulators (STIM) developed with the
aim of achieving optimum pelvic health for women. Kegel8 Ultra 20
works by producing electrical pulses that stimulate the muscles and
nerve bres in your pelvic area.
If you haven’t used a neuromuscular stimulator before, the idea of
applying electric pulses to your body can seem a little strange. But
there’s no need to be concerned - your body already uses electrical
signals all the time. For example, let’s say you want to tense the
bicep muscle in your arm. To do this, your brain sends an electrical
signal to your muscle via your nervous system. When the signal
reaches your bicep, it causes the muscle to contract, and when the
signal is not present, your muscle relaxes again.
Kegel8 Ultra 20 works in a very similar way - it sends electric pulses
to precise areas of the weakened muscles in your pelvic area,
causing them to contract and relax. Over time, this strengthens the
muscles and nerve bres, giving you greater muscle control and
improving tone and tightness.
Kegel8®Ultra 20 features several pre-set programmes for pelvic
oor exercise. These programmes have been carefully planned so
that they:
●Work your muscles appropriately, helping them to strengthen
gradually
●Allow your muscles to rest for the correct amount of time
●Are easy to use in 20-60 minute sessions.
There have been many research papers and clinical trials relating to
neuromuscular stimulation. If you are interested in nding out more,
a list of relevant papers is included in our Clinical References (see
page 60).

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When you rst use Kegel8® Ultra 20, you will need to use
Programme 01 (P01), which is a sensitivity test. This test is
designed to check the current condition of your pelvic oor muscles
and nerves. Following the sensitivity test, you will begin your Kegel8
Ultra 20 exercises using one of the many built-in programmes,
or possibly one of the custom programmes (which allow medical
professionals to create a programme specically for you). The
programmes are designed to treat a variety of female health
problems, so you should choose the exercise that is best suited to
your needs (see Choosing a Kegel8®Ultra 20 Programme on page
29).
At the start of every programme, Kegel8®Ultra 20 begins at 0mA,
which means there is no electrical pulse. When you are ready to
begin, you press the + button for the appropriate channel repeatedly
to increase the electrical current.
When the electrical current reaches a certain level, you will begin
to feel a knocking sensation in your pelvic muscles. This happens
when the electrical current begins to stimulate your muscles at low
levels. You may also feel a tingling sensation. When you get to this
stage, slowly increase the electrical current to a level that is working
your muscles but is comfortable too.
Many women nd that they start to feel their muscles being
stimulated when Kegel8® Ultra 20 is set to around 25mA, with
settings over 30mA giving the muscles a full workout. But everybody
is di󰀨erent, so you need to choose settings that you are comfortable
with. The stronger the sensation you can feel, the more work your
pelvic muscles are doing. But don’t push yourself too hard. If you
feel discomfort, press the - button for the channel to reduce the
current.As you exercise, you will feel your muscles pull up, tighten,
and then relax again.
If you use Kegel8® Ultra 20 as described, 1 or 2 times per day for at
least 3 months, your pelvic muscles will get stronger. This will give
you greater control and you will be able to gradually increase the
amount of current.
Now, let’s get you started - go to (see Starting Your Kegel8® Ultra 20
Exercises on page 18).
What to Expect from Your Kegel8® Ultra 20

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Starting Your Kegel8®Ultra 20 Exercises
Ready to start your pelvic oor exercises? Then let’s get to it!
1. Before you start using your Kegel8®Ultra 20, please read the
Important Safety Information (see page 8).
When used correctly, the Kegel8® Ultra 20 is a safe and
e󰀨ective way of tightening and toning your pelvic oor. But
remember, Kegel8® Ultra 20 is an electrical device and
if misused can cause harm. So please read the Safety
Information carefully.
2. On the back of your Kegel8® Ultra 20, slide o󰀨 the battery cover
and insert the battery. Make sure the red material strip is under
the battery - it makes it easier to remove the battery when a
replacement is needed. Slide the battery cover back on.
3. Make sure the probe is clean by rinsing it in cold or warm water
(see Kegel8® Probe Care on page 47). Unclean probes could
cause infection.
If you are using electrode pads make sure your skin is clean
and free from oils, lotions, moisturisers etc. These types of skin
applications can damage the surface of your electrodes.
4. Connect the lead wire to the probe/pads and Kegel8®Ultra 20
unit. All of the wires are tted with the appropriate connections,
so all you have to do is:
●Insert the red pin on the lead wire into one of the
connections on the probe/pad’s wire.
●Insert the black pin on the lead wire into the remaining free
connection on the probe/pad’s wire.
●Insert the white connection on the lead wire into the
Channel A slot on your Kegel8®Ultra 20 unit. If you are
looking at the front of the Kegel8 unit, the Channel A socket
is on the top-left of the unit. Push the lead in rmly so that it
is fully connected.
If you are going to use an anal probe, connect it to the Channel
B socket. Kegel8® Ultra 20 is designed so that you can use a

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vaginal probe only, an anal probe only, or both a vaginal and
anal probe at the same time. Just make sure that your probes
are connected to the appropriate channels (Channel A for
vaginal, Channel B for anal).
Using pads instead of probes? Just connect one pair of pads to
to Channel A and one pair of pads to Channel B.
5. Insert the Kegel8 probe(s)/apply the pads.
For more information on inserting Kegel8 probes, see Inserting
a Kegel8®Probe on page 23.
For details on applying the Kegel8 pads correctly, see Applying
Kegel8®Electrode Pads on page 24.
6. Press the ON button on the Kegel8 control unit.
7. Press the PRG button to choose a programme (press PRG
repeatedly to cycle through the available programmes):
●P01 (RCV1) - Sensitivity Test
●P02 (RCV2) - Improved Sensitivity Exercise
●P03 (EXE1) - Pelvic Exercises
●P04 (EXE2) - Intense Pelvic Exercises
●P05 (EXE3) - Weekly Maintenance
●P06 (SIMP) - Sensation Improvement
●P07 (ENDU) - Pelvic Floor Endurance
●P08 (SENS) - Pelvic Floor Sensitivity
●P09 (OAB) - OAB Overactive Bladder
●P10 (STR1) - Intermediate Stress Incontinence
●P11 (STR2) - Gentle Stress Incontinence
●P12 (MIXD) - Mixed Incontinence: Urge/Frequency/Stress
●P13 (FTRN) - Improvement of local blood circulation
●P14 (PNC1) - Post natal Incontinence 1

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●P15 (PNC2) - Post natal Incontinence 2
●P16 (BOW1) - Bowel (faecal) incontinence 1
●P17 (BOW2) - Bowel (faecal) incontinence 2
●P18 (PAIN) - Electrode Pads Chronic Back Pain Relief
●P19 (CIRC) - Pelvic Pain & Circulation
●P20 (RELX) - Pelvic Pain & Relaxation
●PC1, PC2, PC3 - (see Creating a Custom Programme on
page 43).
NOTE: If you have never used your Kegel8®Ultra 20 before,
you should begin with Programme P01, which is a sensitivity
test.
For information on selecting an appropriate programme, see
Choosing a Kegel8®Ultra 20 Programme on page 29.
8. Press the + button(s) to start the programme.
If you are only using the vaginal probe, press the + button for
Channel A. If you are only using the anal probe, press the +
button for Channel B. Press both + buttons if you are using two
probes.
When you press a + button, the mA (milliamps) reading for
that channel changes and your programme begins. Once
your programme has started, press the relevant + button to
increase the amount of power (milliamps). The higher the
amount of mAs, the more e󰀨ective your programme will be, but
always choose a level that feels comfortable. If you are feeling
discomfort or pain, reduce the amount of mAs by pressing the -
button for the channel(s) you are using.
CAUTION: When using the probe, you should try to start
each programme, except P08, at around 25mA-30mA. P08 is
a more intense programme, so start much lower and do not
exceed 25mA. When using electrode pads, do not increase the