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