Kegel8 ULTRA User manual

Kegel8® Ultra Operation Manual
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Kegel8® Ultra Operation Manual
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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. afgafadf
Neuromuscular Stimulation (STIM) and EMG Triggered
Stimulation (ETS) should not be used by Patients fi tted with
demand style cardiac pacemakers. Please seek advice from
your health supervisor.
Patient’s shock protection type: BF (Body Floated)
Equipment. 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 identifi 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 - Notifi ed Body identifi 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 20 for the disposal instructions).

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* This unit must be used with the guidance of a Physiotherapist or
Doctor.
* Type BF equipment, Continuous Operation
* 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.
* Do not use the Kegel8® Ultra unit in the presence of a fl 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 directly to a battery charger or to any other mains
powered equipment. We advise not to use Ni-Cad rechargeable
batteries.
* Patient 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 qualifi ed Clinician.
* Application of electrodes near the thorax may increase the risk of
cardiac fi 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.
* No modifi cation of this equipment is allowed!
Warnings

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Contents Page
Warnings 3
What is STIM? 5
Contra Indications & Precautions 6
Description of STIM Unit & Functions 7
Quick Start Instructions 9
Setting up your Customized Programme 11
Lock Button 12
Continence Treatment Programmes 13
Electrode Types & Tips 19
Care, Maintenance, Accessories and Disposal 20
Indications for use 21
Specifi cations 22
Information regarding Electromagnetic compatibility
and interference (EMC) 22
Troubleshooting 26
Warranty 27
Clinical References 28
Contents

Kegel8® Ultra Operation Manual
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Neuromuscular Stimulation has been used for many years to stimulate muscle
and nerve fi bres to treat a number of muscle and nerve related conditions. Over
the last 30 years numerous clinical trials and papers have been written.
The Kegel8® Ultra is one of a new breed of modern Neuromuscular
Stimulators which Verity Medical have developed with the Therapist and
Patient in mind. Our principle aim is to design products that have high levels of
functional use, are sensibly priced, compact and user friendly.
The Kegel8® Ultra is a dual channel device combining several treatment
programmes into one unit. Neuromuscular Stimulation is increasingly
understood by Therapists and Doctors. There is a better understanding of the
mechanisms which exist between nerves and muscles that makes it possible
to stimulate the neuromuscular system with precise electrical signals. The
Kegel8® Ultra off ers precision giving full control of Pulse Widths, Rates, Ramp
up times, Work / Rest cycles as well as alternating or synchronous application
if two channels are being applied.
Customer Care
We welcome constructive comments regarding our equipment particularly
those that might help us to improve existing features, add new ones or develop
new products for the future.
What is STIM?

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Before using this equipment you must fi rst seek the advice of your
Physiotherapist or Doctor.
Read this operating manual before using the STIM unit.
STIM should not be used:
* By patients fi tted with a demand style cardiac pacemakers 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
* Do not place electrodes:
> Over carotid sinus nerves
> Over larynx or trachea
> Inside mouth
> Over the area of the heart unless so advised by your Doctor
> On your facial area unless under strict guidance from a
qualifi 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.
* The patient should use the unit only as prescribed
* Do not immerse the unit in water or any other liquid
* Keep unit out of reach of children
* If in doubt about the use of the STIM unit, call your Doctor,
Therapist, Clinician or your distributor for advice
* Only use CE approved skin electrodes
* Only use CE approved vaginal or rectal probes
Contra Indications & Precautions

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Description of STIM Unit & Functions
LCD
Display
Select
Programme
SET
Channel A Channel B
Lock
Lead Wire
and Pin
Front Rear
* PRG button Selects the desired set programme from P01 - P11 or
customised programme PC1 - PC3.
Pauses (reducing the mA intensity to zero) and
escapes from a running programme.
* SET button Reduces the intensity (mA) to zero and pauses
the programme (if a programme is running) and moves the
phase one step forward.
Displays the menu for programmes PC1 - PC3 and
allows the parameters for Time, Work, Rest, Ramp up
time, CH.A / CH.B Synchronous or Alternating and
delay to be set.
* LOCK button Locks the unit so the home user cannot amend the
treatment parameters nor change the programme. This
button must be used only by the treatment supervisor.
See the details on see page 11.
Connect Probe to
Channel A or B

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•Work
•Rest
•Alt
•Cont
•Mod
Min Min
MA
Lock
symbol
Current phase /
phase indicator
Frequency &
pulse width of phase
Programme
Total
programme
time
Channel A
milliamps
Channel B
milliamps
Time of
current phase
Number of phases
Phase mode
•Work
•Rest
•Alt
•Cont
•Mod
3 Hz
250 uS
PC1
5 : WK
Min
4
SEC
Programme
Total
programme
time adds
cumulatively
as time added
to phases
Set Work / Rest / Ramp / Delay
seconds
Current setting be-
ing altered (work
in this example)
Number of phases
Phase mode
Example of preset programme:
Example of custom programme:
Phase being
set
Low
battery
indicator
3 Hz
250 uS
P08
3 : 2
0 0
MA

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1. Remove battery cover. Insert 1 x 9 volt PP3 battery or a rechargeable
Nickel Metal Hydride battery into the battery compartment. Replace the
cover.
2. Insert the lead wire(s) into the sockets of the unit. Lead colour is not
important. You may use one lead or both leads. If you are only using one
lead wire (for Channel A), insert the lead wire into the right hand socket
(Channel A).
3. Remove the Vaginal or Rectal electrode from its packaging.
4. Connect the Vaginal or Rectal electrode to each of the pin connectors at
the end of the lead wire. The red and black polarity are good either way.
Some probes have a long wire built-in, with the direct socket to the unit.
5. Make sure the Vaginal or Rectal electrode is clean before use.
6. Insert the Vaginal or Rectal electrode using KY jelly or any other water-
based lube (not mandatory).
A typical vaginal electrode placement diagram:
Don’t insert too deep, the neck of the probe should be just inside the vagina,the
metal plates of the probe should be fully inserted.
7. Turn on the unit by pressing the on/off button once.
8. Select the desired programme by pressing the PRG button
(please refer to the programme tables on page 11).
Quick Start Instructions

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9. Hold down the A+ button until you feel a strong but comfortable current.
The current may be decreased by pressing the A- button.
10. You may adjust the strength of the current during the treatment by press-
ing the A+ or A- buttons.
11. To exit the programme before it is fi nished, turn off the unit by pressing
the on/off button once.
12. Important: Do not remove your probe / electrodes while the unit is run-
ning.
13. Carefully clean Vaginal or Rectal electrode before and after use. Wash
the probe gently in mild soapy water, rinse and make sure the probe is
completely dry before returning to storage in the plastic bag.
Low Battery Indicator
When the battery power is low, the low battery indicator will appear on the
screen (shown in the diagram on page 7). When the battery indicator shows
one bar, replace the battery.
Disconnection Indicator
When the probe becomes disconnected or when the lead wires do not conduct
the electrical current, the milliamp level will return to zero and the eff ected
channel will fl ash on and off .
Common Issue:
If you press + button but the intensity stops at 6-9 mA and cuts off to zero
and you see 0 mA fl ashing on the screen:
- This is a typical situation for any muscle stimulator. You are experienc-
ing the safety cut off due to no electrical load on the output. You should
be able to resolve this issue yourself, please folow the troubleshooting
chapter on page 25.

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First, if a programme is running, press the PRG button twice to return to the
home screen.
Refer to the example of custom programme diagram on page 7.
1. Press the PRG button until PC1, PC2 or PC3 is selected.
2. Press and hold the SET button for three seconds, the phase indicator
arrow and Hz symbol will fl ash on and off .
3. Press CH.B +/- to set the fequency between 2 Hz and 100 Hz.
4. Press CH.A +, the µS symbol will fl ash, press CH.B +/- to set the
pulse duration between 50 µS and 330 µS.
5. Press CH.A +, the MIN symbol will fl ash, press CH.B +/- to set
the length of the phase time between 1 and 99 minutes.
Set the time to zero to end the programme on this phase.
6. Press CH.A +, the WORK / REST or the CONT symbols will fl ash,
Press the CH.B +/- to select WORK / REST or CONT (continuous).
Note: if continuous is selected, the menu will loop back to step 2.
7. Press CH.A +, WK will appear and fl ash, press CH.B +/- to set the
work seconds between 2 and 99 seconds.
8. Press CH.A +, RT will appear and fl ash, press CH.B +/- to set the rest
seconds between 2 and 99 seconds.
9. Press CH.A +, RP will appear and fl ash, press CH.B +/- to set the ramp
seconds between 0.1 and 9.9 seconds.
10. Press CH.A +, AL or SY will appear and fl ash, press CH.B +/- to
select alternating or synchronous current.
Note: if alternating is selected, the menu will loop back to step 2.
11. Press CH.A +, DY will appear and fl ash, press CH.B +/- to set the
delay of channel B starting between 0 and 4 seconds after channel A.
12. The menu will now loop back to step 2 and the Hz symbol will fl ash.
13. To set the next phase, press the set button. The phase symbol will fl ash
over the next phase, continue with step 2 to set this phase.
14. When fi nished setting the phases, press the PRG button to save the
settings and return to the home screen.
The programme will be saved permanently.
Setting the phase time of phase 2,3,4 or 5 to zero will cause the programme to
end at that phase.
Following procedures 1 to 12 you can reprogramme a customised programme.
If for example there are 5 pre-set phases in one overall programme and only
4 phases are now required, input 0 (zero) into the phase time that is no longer
required and press the PRG key to store the new information.
Setting up your
Customized Programme

Kegel8® Ultra Operation Manual
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A “concealed” lock button is included in the Kegel8® Ultra which allows the
clinician to accurately monitor “Home Compliance” of the patent between
appointments. It records the time in use and the average intensity (MA). It also
locks the customised programmes, stopping them from being altered.
You can lock the unit to start measuring the statistics of use and make sure the
programme parameters stays the same. To change or modify the programme,
fi rst unlock the unit. Unlocking will clear the statistics.
To Lock the Unit
1. Select the pre-set or customised programme required. In the case of
a customised programme, make sure that the pulse width, frequency,
time etc. are set-up correctly.
2. Remove the battery cover and, using a thin rod gently press on the
lock button as shown in the diagram on page 6 until you hear a
double beep. The unit is now “locked” and cannot be altered until
“unlocked”. Note: The lock symbol will appear on the LCD when
the unit is “locked”.
To Unlock the Unit
Remove the battery cover and press the concealed switch with a thin rod until
a single beep is heard. Now the LCD will display the average mA used on each
channel and the total hours and minutes the unit has been in use as shown in
the diagram. To return to normal “unlocked” operation, simply press SET.
Lock Button
•Work
•Rest
•Alt
•Cont
•Mod
10 Hz
200 uS
P08
3 : 2
Min
30 20
MA MA
Lock symbol
(fl ashes when being
unlocked)
Frequency & pulse
width of phase
Programme
Hours and
minutes unit
was used in
the locked
mode
Average millamps
CH.A
Average milliamps for
CH.B
Minutes
Number of phases
Phase mode
Min

Kegel8® Ultra Operation Manual
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Continence Treatment Programmes
Programme: P01 Pelvic Floor
Pain
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 20
Mode Cont
Frequency work Hz 3
Pulse duration µS 150
Ramp up time secs 1.0
Ramp down time secs 0
Work time secs Cont
Rest time secs 0
Alternating
Synchronous *
Overall time 20 min
Programme: P02 Urge
Incontinence
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 20
Mode W/R
Frequency work Hz 10
Pulse duration µS 250
Ramp up time secs 1.0
Ramp down time secs 0
Work time secs 5
Rest time secs 5
Alternating
Synchronous *
Overall time 20 min

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Programme: P03 Stress
Incontinence 1
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 20
Mode W/R
Frequency work Hz 40
Pulse duration µS 200
Ramp up time secs 1.0
Ramp down time secs 0
Work time secs 6
Rest time secs 15
Alternating
Synchronous *
Overall time 20 min
Programme: P04 Stress
Incontinence 2
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 20
Mode W/R
Frequency work Hz 30
Pulse duration µS 200
Ramp up time secs 0.8
Ramp down time secs 0
Work time secs 5
Rest time secs 8
Alternating
Synchronous *
Overall time 20 min

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Programme: P05 Frequency
/ Urge 1
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 20
Mode W/R
Frequency work Hz 10
Pulse duration µS 200
Ramp up time secs 1.0
Ramp down time secs 0
Work time secs 5
Rest time secs 5
Alternating
Synchronous *
Overall time 20 min
Programme: P06 Frequency
/ Urge 2
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 15
Mode Cont
Frequency work Hz 10
Pulse duration µS 200
Ramp up time secs 1.0
Ramp down time secs 0
Work time secs Cont
Rest time secs 0
Alternating
Synchronous *
Overall time 15 min

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Programme: P07 Frequency
/ Urge 3
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 20
Mode Cont
Frequency work Hz 10
Pulse duration µS 220
Ramp up time secs
Ramp down time secs
Work time secs
Rest time secs
Alternating
Synchronous *
Overall time 20 min
This programme works continuously with no rest period. It is used in some countries
where they have found continuous stimulation can work eff ectively.
Programme: P08 Lack of
Sensitivity
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 3 10 5 4 3
Mode W/R W/R W/R W/R W/R
Frequency work Hz 3 10 20 30 40
Frequency rest Hz
Pulse duration µS 250 250 250 200 200
Modulation time secs
Ramp up time secs 0.8 0.8 0.8 0.7 0.7
Ramp down time secs 0 0 0 0 0
Work time secs 4 4 4 4 4
Rest time secs 4 4 4 6 6
Alternating
Synchronous * * * * *
Overall time 25 min

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Programme: P09 Pelvic Floor
Work Out
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 4 15 8 8 10
Mode W/R W/R W/R W/R W/R
Frequency work Hz 20 10 20 30 10
Pulse duration µS 250 250 250 200 250
Ramp up time secs 0.8 0.8 0.8 0.6 0.8
Ramp down time secs 0 0 0 0 0
Work time secs 5 5 5 5 5
Rest time secs 5 5 5 6 7
Alternating
Synchronous * * * * *
Overall time 45 min
Programme: P10 Building Up
Endurance
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 20
Mode W/R
Frequency work Hz 20
Pulse duration µS 250
Ramp up time secs 0.8
Ramp down time secs 0
Work time secs 5
Rest time secs 5
Alternating
Synchronous *
Overall time 20 min

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W/R = INTERMITTENT WORK/REST
CONT = CONTINUOUS
Programme: P11 Relaxing the
Pelvic Muscle
Phase 1 Phase 2 Phase 3 Phase 4 Phase 5
Phase time min 20
Mode W/R
Frequency work Hz 2
Pulse duration µS 220
Ramp up time secs 1.2
Ramp down time secs 1.2
Work time secs 6
Rest time secs 10
Alternating
Synchronous *
Overall time 20 min
This programme helps to relax the pelvic muscle. It may be used where the EMG
readings are high, in the region of 8 microvolts or more or when the pelvic muscle has
been working hard and some fatigue may have occured. The very low frequency (2 Hz)
will help to relax the muscle.

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* Self-Adhesive reusable long-term electrodes (if looked after) have a
typical life span of 4/6 weeks. We recommend cleaning the skin with an
alcohol-based wipe before placing the electrodes. The wipe should not
contain fat as any grease will degrade the electrode stickiness. After use,
place the electrodes back onto the plastic fi lm and in the zip-tag plastic
pouch. Store in a cool environment which is not too dry.
Skin Electrode Types Available:
Electrodes Types and Tips
A Few Good Tips [Self- Adhesive Electrodes]
* If you fi nd the electrodes will not stick due to oily skin, cleanse the
skin with soap and water, then rinse and dry the area around the
electrode site. If this does not work, try cleansing the skin with a swab
impregnated with alcohol.
* Clip away hairy skin using scissors; don’t use a razor to remove the hair!
* The electrodes conductive material is water- based. If it becomes
saturated (e.g. from perspiration), it will lose its adhesive qualities.
After use leave the electrodes face up overnight to dry out (replace on
plastic fi lm in the morning).
At some point the electrodes will become dry. Moisten the adhesive
surface with a few drops of water, and apply onto the plastic fi lm
overnight. This procedure will increase the electrode life by few more
days.
Shape Code Description
VS.4040 40 x 40 mm, square (* max 53mA)
VS.5050 50 x 50 mm, square
(recommended for general use)
VS.9040 90 x 40 mm, rectangular
VS.9050 90 x 50 mm, rectangular
VS.10050 100 x 50 mm, rectangular
VS.30 30 mm diameter, round
(* max 46mA)
VS.50 50 mm diameter, round
* IMPORTANT : Don’t use VS 4040 at more than 53mA and
VS3030 at more than 46 mA.

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WARNING! Only medically approved accessories should be used!
CONTROL UNIT:
* Wipe the surface once a week with a damp cloth or antiseptic wipe or
baby wipe.
* Do not use cleaning sprays or alcohol based cleaning solutions
* Control unit disposal: please return to Verity Medical LTD or to the
appointed distributor
ACCESSORIES
Battery:
* To change the battery, open the battery door on the rear of the control
unit by pressing down on the raised rib pattern just below the belt clip.
Lift the battery out of the compartment. This is very easy and can be
done by the user.
* Check periodically for any discharge from the battery
* Remove battery completely from unit if not in use for any extended
period of time (typically one week)
* Low battery indicator of 6.9 volts shown on LCD display. When
fl ashing change battery for a new one
* Preferably use a PP3 alkaline battery
* Battery disposal: please return to the supplier from whom
you’ve purchased it.
Lead Wires:
* The lead wires should be handled carefully and never stretched, as
this can cause the stimulation to function below normal standards or
not at all
* Examine lead wires before each treatment for loose connections or
damage
* Avoid stretching and twisting the lead wires
* Store the lead wires carefully after each use
* Lead wires Disposal: please return to the supplier from whom
you’ve purchased them.
Care, Maintenance,
Accessories and Disposal