Kegel8 Tight & Ton User manual

Kegel8® Tight & Tone Operation Manual
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Kegel8® Tight & Tone 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.
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 14 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 protect from the ingress of water droplets from a shower
of rain if used outside the carrying case.
* Do not use the Kegel8® Tight&Tone 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® Tight&Tone 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.
* This device can deliver current densities in excess of 2mA/cm2 when
used at a high intensity with small electrodes. See page 10 for more
details.
* No modifi cation of this equipment is allowed!
Warnings

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Contents Page
Unit symbols explanation 2
Warnings 3
What is STIM? 5
Contra Indications & Precautions 6
Description of STIM Unit & Functions 7
Quick Start Instructions 8
Lock Button 10
Pelvic Floor Treatment Programmes 12
Electrode Types & Tips 13
Care, Maintenance, Accessories and Disposal 14
Indications for use 15
Specifi cations 16
Information regarding Electromagnetic
compatibility and interference (EMC) 17
Troubleshooting 21
Warranty 22
Clinical References 23
Contents

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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® Tight&Tone 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® Tight&Tone is a dual channel device combining several treat-
ment 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® Tight&Tone 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
Contraindications & Precautions

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Description of STIM Unit & Functions
* PRG button Selects the desired set programme from P01 - P09 or
customised programme PC1 - PC3.
* SET button This button works only for programmes PC1-PC3.
Press SET button inside the battery compartment to set
parameters of your custom treatment: Pulse Rate, Pulse
Width, Time, etc.
* ESC button Stores customised programme and returns to the
home position.
Front Back
LCD
Display
Select
Programme
SET
Channel A Channel B
Lock
ead Wire
and Pin
ESC

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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 any electrically-conductive
lubricant like 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
pressing 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
running.
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
experiencing the safety cut off due to no electrical load on the output.
You should be able to resolve this issue yourself, please follow the
troubleshooting chapter on page 21.

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Lock Button
A "concealed" Lock button is included in the Kegel8® Tight&Tone which al-
lows the clinician to accurately monitor "Home Compliance" of the patent
between appointments. It also locks the customised or built in programmes.
To Lock the Unit
1. Select the built in or customised programme required. In the case of
a customised programme, make sure that the pulse width, frequency,
time 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"
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 the unit has been in use as shown in the diagram.
To return to normal "unlocked" operation, simply press ESC.
Hours Used 45
20mA 20mA
Ch.A Ch.B

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Setting up the Customised Programme PC1, PC2 or PC3
Select PC3, PC2 or PC3 by pressing the PRG button on the front panel.
1. Press and hold the SET button for 3 seconds until Hz symbol will fl ash
on the display, then press the + or – button to adjust the pulse rate.
2. Press the SET button again and the µs symbol will fl ash on/off , then
press the + or – button to adjust the pulse duration from 50 - 450µs.
3. Press the SET button again and the Clock [Time] symbol will fl ash on/
off , then press the Channel A +/- button to alter the hours and Channel B
+/- button to adjust minutes.[Maximum time 1 hour 30 minutes].
4. Press the SET button again and the WRK [Work] symbol will be
displayed, then press the + or – button to adjust the work period
from 2– 99 seconds.
5. Press the SET button again and the RST [Rest] symbol will be displayed,
then press the + or – button to adjust the rest period 2 – 99 seconds.
6. Press the SET button again and the RMU [Ramp up] symbol will be
displayed, then press the + or - button to adjust the ramp up period from
0.1 - 9.9 seconds.
7. Press the SET button again and RMD (Ramp down) symbol will be
displayed, then press the + or - button to adjust the ramp down period
from 0.1-9.9 seconds.
8. Press the SET button again and SYN (Synchronous) symbol will fl ash
on/off . This is recommended for pelvic fl oor disorders. If you have
been advised to use ALT (Alternating) mode, press + or – button to select
ALT. Otherwise leave as SYN and go to next mode.
9. Press the SET button again. If SYN is selected in point 8, the DLY (Delay)
symbol will fl ash on/off . Press the + or – button to adjust the delay time
0-4 sec. For typical use, leave 0 seconds. If the delay is set above zero,
the channel 2 will ramp up with the delay.
After setting up the programme, press the ESC button to install and store the
customised programme. Repeat the above procedure to re-programme.
Note: You must press the ESC button before locking the unit.

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No. Programmes
Rate
[Hz]
Pulse
Width
[µS]
Ramp up
time
[sec]
Work
time
[sec]
Rest
time
[sec]
Overall
time
[min]
P01 PAIN RELIEF 3 150 1 CONT 20
P02 URGE 10 250 1 5 5 20
P03 STRESS-1 40 200 1 6 15 20
P04 STRESS-2 30 200 0.8 5 8 20
P05 FREQ/URGE-1 10 200 1 5 5 20
P06 FREQ/URGE-2 10 200 1 CONT 15
P07
LACK OF
SENSITIVITY
[25 min]
Sequential: 3Hz for 3mins,10Hz for 10mins,
20 Hz for 5mins,250µS,
ramp up time 0.8 secs,
30Hz for 4mins, 40Hz for 3mins, 200µS
ramp up time 0.7sec,
work time 4sec,rest time 4sec
P08
PELVIC
FLOOR
WORK OUT
[60 min]
Sequential:
20Hz for 3mins,
3Hz for 5 mins,
10 Hz for 15 mins,
20 Hz for 15 mins:
(250 µS, ramp up time: 0.8 sec).
30Hz for 5mins,
40Hz for 5mins:
(200µS, ramp up time: 0.6 sec).
10Hz for 12mins:
(250µS, ramp up time: 0.8 secs).
Work time 4sec, Rest time 4 sec.
P09
BUILDING UP
ENDURANCE
P09
20 250 0.8 5 5 20
CUSTOM
PC1, PC2, PC3
Pelvic Floor Treatment Programmes

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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 hairs!
* 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 x50 mm, square
(recommended for general use)"
VS.9040 90x40mm, rectangular
VS.9050 90 x 50 mm, rectangular
VS.10050 100 x 50 mm, rectangular
VS.30 30mm 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 after each use 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.
Self-Adhesive Electrodes:
* Check the short connectors have not become separated from the
electrodes
* Replace electrodes onto plastic fi lm after use. If they drop onto the
fl oor debris will adhere to conductive gel rendering the electrodes
ineff ective
Care, Maintenance,
Accessories and Disposal

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Electrode life can be considerably reduced by:
* The type and condition of the skin
* Deep seated moisturisers or make-up
Vaginal / Rectal Probes:
* Check the connectors have not become separated from the probe
* We advice you to use Verity Medical’s VeriProbe.
* Vaginal Probe Disposal: please return it to the supplier from whom
you’ve purchased it.
Caution: Static electricity may damage this product
NOTE: Only Verity Medical Ltd or appointed distributors /importers
are approved to undertake servicing.
* Pelvic pain
* Stress incontinence
* Overactive bladder (urge incontinence)
Also used for non medical purposes:
* Pelvic fl oor strength, endurance, vascularisation and relaxation
Indications for use

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Specifi cations
STIM
1. Dual channel: individually isolated circuits.
2. Amplitude: 0 - 90 mA into 500 Ohm load; indication only. Actual mA
will tend to be less than indicated due to electrode impedance: at
1000 Ohms load (Electrodes in poor condition) the maximum
will be limited to 70 mA, at 1500 Ohms load the maximum
will be limited to 65 mA.
3. Type: Constant current,
maximum output voltage 180 Volts +10 / -30 Volts
4. Waveform: Asymmetrical, rectangular bi-phasic with zero DC
current.
5. Selectable pulse width: 50µS – 450µS [10% accuracy].
6. Pulse Rate selection: in the continuous mode 2 – 100 Hz
[5% accuracy].
7. Time duration of the treatment selectable: 1 minute to 90 minutes.
8. Ramp up time 0.3 - 9.9 seconds.
9. Battery: PP3 Alkaline, 9V.
Expected average battery life [of standard 800 mAh, alkaline]:
32 hours.
10. Low Battery Indicator: If the battery goes below 6.9 volts +/- 0.2
volts the battery symbol will fl ash on/off once every second.
11. If the battery voltage is below 6.6 (+/- 0.2) volts the unit
will not turn on.
12. Open Electrode Detect: If an open circuit is detected at the
output of channel A or B the output current will be reset at zero.
Expected service life:
5 years. Careful use and maintenance extends the life of the unit over the
service life limit.
Physical dimensions:
119.2 x 69 x 28.7 mm
Weight:
100g with battery.
Environmental Conditions for use:
+5 to +40 degrees Centigrade. 15-93% Humidity.
Environmental conditions for storage & transport:
-25 to +70 degrees Centigrade, 15-93% Humidity.

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Information regarding Electromagnetic
compatibility and interference (EMC)
Kegel8® products are designed to produce very low levels of radio
frequency (RF) emissions (interference), to be immune from eff ects
of interference produced by other equipment operating in their vicin-
ity and damage due to electrostatic discharge all when operating in a
typical domestic and or clinical environment. They are certifi ed to meet
the international EMC standard EN60601-1-2. For more information
please refer to the tables 201, 202, 204 and 206.

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