TensCare iTouch Sure Troubleshooting guide

TensCare Ltd, 9 Blenheim Road,
Longmead Business Park,
Epsom, Surrey KT19 9BE, UK
Tel [phone]
Email: [email protected]
www.tenscare.co.uk
Instructions for Use
Distributed by:
Pub Ref: I-ITS-UK Rev 2.3 2/14
PELVIC FLOOR EXERCISER
sure

Contents
Section Page
1 Introduction 1
2 Types of Incontinence 3
3 Advantages of the “itouch Sure” 3
4 How Continence Stimulation Works 4
5 The Programmes 5
6 Cautions and Warnings 9
7 Controls 12 -16
8 Screen Information 17
9 Usage Memory 18
10 Leads Alarm 19
11 Contents 19
12 Installation of Batteries 20
13 Using the “itouch Sure” 21
14 Cleaning 23
15 Anal Probe 23
16 Battery Removal and Replacement 25
17 Helpline 26
18 Troubleshooting 26
19 Consumables and Servicing 29
20 Guarantee 30
21 WEEE 31
22 General Specifications 32
23 Electromagnetic interference 33
INTELLIGENT CONTINENCE STIMULATOR

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1. INTRODUCTION
The “itouch Sure” may help, if not cure, Stress, Urge or
Mixed Incontinence.
The “itouch Sure” was developed in conjunction with professional
continence advisers, taking into account feedback from users of
our existing products. The “itouch Sure” offers the best results, is
comfortable and easy to use.
“itouch Sure” features:
• Comfortable Stimulation TM
The strength of the stimulation increases gradually, making the
feeling very comfortable and in your control.
• Easy Start - One Touch Memory
The “itouch Sure” has intelligent memory that enables the unit
to remember the last programme and the strength setting used.
At the press of only one button the strength level returning to
75% of the last level used.
• Clinically tested programmes
The programmes which have been preset into the unit have been
clinically tested and proven to be highly effective.
• Safety Duration Override
A safety duration override feature has been incorporated into
the “itouch Sure” to ensure that the pelvic floor muscle is not
overworked. This is set at twenty minutes after which time the
unit will switch off. It is possible to alter the time in order to
customise the unit to your needs.
• Usage Memory
The “itouch Sure” has a Usage Memory which shows the length
of time that the unit has been in use and the average level of
strength utilised.

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2. TYPES OF INCONTINENCE
There are three types of incontinence: Stress, Urge, and Mixed.
• Stress Incontinence
Describes the involuntary leakage of urine when a person coughs,
sneezes, strains or makes sudden movements. It is particularly
common in women and occurs when the bladder neck and the
other mechanisms that act to hold urine in the bladder are not
working properly.
• Urge Incontinence
Describes an overactive bladder. A person may experience a strong and
sudden urge to go to the toilet but are not always able to hold on, or
have to go so frequently that it becomes inconvenient.
• Mixed Incontinence
Is a combination of both Stress and Urge Incontinence.
3. THE ADVANTAGES OF “itouch Sure”:
• It can be a Cure - not simply containment.
• It is Drug Free with no side effects.
• It is Safe and Easy to use.
• It is Discreet.
• It may help to avoid surgery.
• It may improve sexual intimacy.
4.HOW CONTINENCE STIMULATION WORKS
The “itouch Sure”, through a vaginal probe or pads, sends a gentle
stimulation to your pelvic floor muscles using clinically recognised
programmes .The “itouch Sure” works the pelvic floor muscles for
you and helps you to develop your own muscle control. It perfectly
compliments pelvic floor excercises. The “i touch Sure”is the result of
considerable research and consultation with continence advisors.
It is also possible to treat faecal incontinence in both males and females
using an anal probe.
Please note that we strongly recommend the Liberty vaginal probe (as
supplied with the unit) and the Type X-AP anal probe.
In some instances, where a probe is not appropriate - particularly with
Urge Incontinence - it is possible to treat incontinence by using electrode
pads placed on the body.
If in doubt contact your continence adviser before using the
“itouch Sure”.

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5. CONTINENCE PROGRAMMES
The “itouch Sure” has four preset programmes. One for each type
of incontinence and a fourth for toning of the pelvic floor muscles.
STRESS INCONTINENCE:
Shown on the screen as: “STRES”
The STRESS incontinence programme
strengthens the muscles of the pelvic floor using
gentle stimulation. Once muscular strength has
been improved these muscles 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 thereby building their strength.
Successful treatment requires stimulation once
a day for one to three months. Improvement
starts becoming apparent after about four
weeks. It helps to keep a record of leakage
problems so that you have an objective
measure of your progress.
The sensation is like a strong drawing in of
the muscles of the vagina, pulling up of the
pelvic floor. Your natural reaction will be to
pull in and up your muscles, thereby
exercising and strengthening them.
URGE INCONTINENCE:
Shown on the screen as: “URGE”
The URGE incontinence programme reduces
the involuntary contractions of the pelvic
floor muscle. This prevents the unwanted
and unexpected emptying of the bladder.
Successful treatment will require stimulation
once a day and improvements can be seen in
as little as two weeks.
The sensation is of a longer and softer pulling in
of the pelvic floor than the Stress programme.
Nevertheless when the programme finishes, and
your pelvic floor relaxes, it will become apparent
how much your pelvic floor has been exercised.
MIXED INCONTINENCE:
Shown on the screen as: “MIXED”
This programme is perfect if you are suffering
from both Stress and Urge incontinence or
are not sure which form of incontinence is the
problem. Both the forms of stimulation which
occur in the previous two programmes occur
simultaneously in this programme.
The sensation, as you might expect, is like
a combination of both the Stress and Urge
programmes. The overall effect is not such
a strong feeling as the Stress programme plus
a slight pleasurable throbbing sensation.

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TONE:
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 sensation
when using the Tone programme is a mixture of
a strong drawing in of the muscles and then
releasing. The programme repeats the sensation.
A strong and fit pelvic floor muscle will increase
sexual health and enjoyment.
GENERAL POINTS
i) The Stress, Mixed and Tone programmes exercise the pelvic floor
muscles. The sensation is like a strong drawing in of the muscles of the
vagina, pulling up of the pelvic floor. The muscle MUST contract in order
to give a benefit. Increase the strength as high as is comfortable, and then
take it back down one step. The level required varies widely between users
- some will use the “itouch Sure” at full power - 99.5.
ii) It is advisable not to ‘overdo’ it early on. As long as you can feel the
contraction, it is working. You can build up slowly over a number of
days. With the first few sessions the muscles may ache the next day- the
same reaction you would get with any unaccustomed exercise. With the
pelvic floor, this gives a ‘cramping’ feeling. If this happens, stop using
your “itouch Sure” until the aching goes away, then start again using a
lower strength and a shorter treatment time. As the pelvic floor begins to
improve, it will be possible to maintain the stimulation for longer.
iii) The Urge programme works differently. There is no need to have a
contraction. As long as you can feel the stimulation easily, it is working.
You may need to increase the strength during the treatment session.
iv) For best results in the stress and mixed programmes try to contract
the pelvic floor muscles along with the “itouch Sure”, and to sustain the
contraction into the rest interval. If possible, link the contraction to your
breathing in order to get into a gentle rhythm.
v) Once the pelvic floor has been strengthened using the “itouch Sure” ,
continue to exercise the pelvic floor muscles. The pelvic floor needs to be
worked and reacts very well to such exercises.
vi) 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.
vii) All programmes cycle between “work” and “rest” to allow your
muscles to recover in between contractions. During the “rest” period, the
strength display flashes “000”.
viii) When you change the strength setting, this cycle stays on “work”
until you stop pressing the buttons for more than 5 seconds.
ix) The usages mentioned for each programme are guidelines only, and
may be altered depending on your personal needs.

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6. CAUTIONS AND WARNINGS
Do NOT use the “itouch Sure” under the following circumstances:
• With the optional self adhesive pads if you have a heart
pacemaker or have a heart rhythm problem.
Stimulation in the direct vicinity of a pacemaker may affect
some models. Stimulation on the front of the neck can affect
your heart rate. Very strong stimulation across the chest may
cause an extra heartbeat.
• If you have been diagnosed or treated for cervical cancer.
In vitro experiments have shown that electricity can promote
cell growth.
• If you have epilepsy. TENS may affect seizure threshold.
• If you are pregnant. It is not known whether electrical
stimulation may affect foetal development.
• When driving, operating machinery, or similar actions needing
fine control, Loose pads, damaged leads, or sudden changes in
contact may cause brief involuntary muscle movements
BEFORE USE, PLEASE READ THE FOLLOWING WARNING:
• Incontinence can have many causes. You should try to
identify the type of incontinence and the cause before using
the “itouch Sure”.
• If you have a urinary infection or any skin irritations within the
vagina, it is recommended not to use the “itouch Sure”.
• Care must be taken if you are not experiencing normal
sensation or feeling in your vagina. Please see the section about
inserting the probe.
• If you have prolapse, or any discomfort occurs when inserting
the probe, consult your medical advisor before use.
NB: You may safely use the stimulator during menstruation,
although it may be a little less comfortable.
CAUTION:
• Observe caution when using the Itouch Sure at the same time
as being connected to monitoring equipment with body worn
electrode pads it may interfere with the signals being monitored.
• Strong electromagnetic fields (electrosurgery/microwave
cookers/mobile phones) may affect the correct operation of
this unit - See section 21. If it appears to behave unusually,
move it away from these devices.

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7. CONTROLS
Programme
Selector
Lock Button
Strength
UP
Strength
DOWN
ON
Time
Selector
OFF
• Use caution following recent surgical procedures. Stimulation
may disrupt the healing process.
• Simultaneous connection to a high frequency surgical
equipment may result in burns and damage to the stimulator.
• The stainless steel in the probes contains some nickel.
Also do not :
• Immerse your unit or electrodes in water or place it close to
excessive heat. It may cease to operate correctly.
• Attempt to open up the unit. This will invalidate the guarantee.
• Mix old, new or different types of batteries.
• Use this device with leads, electrodes, and accessories other
than those recommended by the manufacturer in section 19.
Performance may vary from specification

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OFF Button
To switch unit off: Press and hold down
the button for 3 seconds and the unit
will switch off. Alternatively, press and
release the OFF button until the LCD screen
displays 0, any further press will switch
the unit off.
When the unit switches OFF an audible
double “Beep” will be heard.
NOTE: Always check unit is OFF before
removing probe or pads.
Strength UP Button
To increase strength: Press and hold
down until required strength is achieved.
Press and release to increase in soft and
gentle 0.5 steps. The unit will remain
in the WORK part of the cycle for 5
seconds while intensity is being adjusted.
ON Button
To switch unit on:
Press and hold down for 3 seconds.
When the unit is switched ON an audible
“Beep” will be heard.
One Touch Memory Start
When switched on the unit will
automatically start in the programme
which was being used when it was
switched off. The strength returns to
50% of the level that was being used
when the unit was switched off.
This simplifies start up dramatically.
During start up to stop the increase in
strength at any time, press any key once.

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Strength DOWN Button
To decrease strength:
Hold down button and strength will
decrease steadily in 0.5 steps
Programme Button
The “itouch Sure” has specifically
selected programmes. When you FIRST
switch on the unit automatically goes to
programme STRES. Next time it is switched
on it will default to the programme last
used.
Each time the “P” button is pressed and
released the programme changes. The
screen will show the programme selected.
Lock button
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 button for 3 seconds until LOCK is
displayed on the screen. Repeat to deactivate.
Time Selector button
Each time you switch on the “itouch Sure”
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 repeatedly pressing and releasing the
Timer button you can manually override
and select 10, 30, 45, 60, 90 minutes or
continuous time. 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 3 seconds,
you can PAUSE the timer, allowing you to
interrupt the treatment session, and resume
it later. Return to main screen by pressing
any other key.

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8. SCREEN INFORMATION
Programme
selected
Time
remaining
Strength
selected
Illuminated screen:
The screen is illuminated whenever a button is pressed.
9. USAGE MEMORY
The “itouch Sure” has a usage memory which remembers the
length of time and average strength that has been used.
To activate hold down the Time Selector and strength UP buttons
together for 3 seconds.
The screen will show the time in hours (to the nearest hour) and
strength..
Hold down Time Selector and strength DOWN button together for
3 seconds to reset the memory to zero.
Strength
UP
Average
strength
Indicates
usage
Time in
hours
Time Strength
DOWN

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10. LEADS ALARM
The “itouch Sure” monitors the connection
and the contact between you and probe,
or pads.
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 strength to zero.
Check the lead and if necessary, lubricate
the probe.
11. CONTENTS
• “itouch Sure” continence stimulator
• Liberty vaginal probe X-VP
• Connecting Lead wire
• 2 x 1.5v AA batteries
• Instruction booklet
• Transit pouch
12. INSTALLATION OF BATTERIES
Remove Battery Cover
Press down in centre of battery cover
and slide backwards in direction of
raised arrows.
Insert batteries
Ensure that the ribbon goes behind the
batteries to aid removal.
Ensure that the batteries are inserted the
right way as shown in battery compartment
When the batteries are running low a low
battery indicator will show on the screen
(battery symbol).
Although the display fades as the batteries
run down, the strength of the output does
not change until the warning is shown.
NB: Remove batteries from your
itouchSURE if the unit is unlikely to be
used for a long period.
!

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13. USING THE “itouch Sure”
Setting up and using the “itouch Sure” is very simple
Step 1: Insert batteries into unit. To test that the batteries have
been fitted correctly and that the unit is working press and
release the “ON” button once. The screen will light up and the
sounder will bleep. Press and release the OFF button once to
turn off the unit.
Step 2: Plug the connecting lead wire
into the “itouch Sure” as shown right.
Step 3: Connect the other end of the
connecting lead wire to the probe.
Step 4: Insert the probe.
Please note:
• Before inserting the probe go to
the toilet.
• Ensure the “itouch Sure” is
switched OFF before insertion.
• Lubricate the probe with a proprietary
jelly, such as KY, TensCare Go Gel or water.
• Insert the probe into the vagina, in the same way as a tampon,
until only the flange at the end is visible. The probe will
naturally position itself with the widest part of the
flange vertically.
• Initially the sensation through the probe 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.
• If using optional pads for Urge, place the pads either side of the
spine, as low as possible.

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14. CLEANING
The Liberty vaginal probe - that is supplied with the “itouch Sure”
is intended strictly for single patient use. It is important that the
probe is cleaned after each use. Clean with either an alcohol-free
antibacterial wipe or by washing in warm soapy water, rinse and dry
thoroughly. Do not immerse the probe in a liquid. Clean the case of
the unit and lead wires at least once a week using the same method.
• Do not immerse your Sure machine in water.
• Do not use any other cleaning solution
15. ANAL PROBE
An anal probe (X-AP or X-PR13) can be purchased as an accessory.
This probe can be used for faecal incontinence in both males
and females.
Conditions that may be treated
These anal probes may be used to treat Urinary and Faecal
Incontinence in a similar way to the vaginal probe.
Because the stimulation cannot be restricted to one muscle group,
and the mucosal tissue has different electrical characteristics, anal
stimulation is less comfortable than vaginal.
You should consult your physician before starting treatment.
Faecal Incontinence
Faecal continence can be the result of weakened or poorly
functioning anal sphincter muscles or damage to the nerves
controlling them. The purpose is to re-educate the anal sphincter
and other muscles of the pelvic floor to contract. The treatments aim
to progress towards graduated active exercises, in order to improve
pelvic floor muscle strength and endurance and to regain function.
You may benefit from the Sure if you either have no active anal
sphincter contraction, or a weak or poorly sustained contraction.
Use the STRESS or TONE programmes.
Intensity should be as strong as possible without being painful.
When possible, try to contract the muscles at the same time as the
Sure.
Post Prostatectomy Urinary Incontinence
Electrical stimulation has been found to help urinary incontinence
in men after radical prostatectomy in some trials.
Use the same programmes as for vaginal stimulation.
Increase intensity in Stres, Mixed, or Tone programmes to the
highest tolerable.

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16. BATTERY REMOVAL AND REPLACEMENT
When the batteries need to be changed the low battery sign,
“BATT”, will be displayed on the screen. To remove batteries pull
gently on ribbon that goes around the back of the batteries.
Battery type:
ONLY use either 1.5v AA alkaline batteries or NiMH AA
rechargeable batteries. NEVER attempt to recharge an alkaline
battery - There is a risk of explosion. DO NOT mix batteries of
different types.
Disposal:
Always dispose of batteries as per government guidelines, see
section 20.
Never put batteries in a fire nor try to disassemble them
Warning:
• Keep batteries out of the reach of small children
• If battery leakage occurs and comes in contact with the skin or
eyes, wash thoroughly with lots of water.
• Do not attempt to revive alkaline batteries by heating,
charging or other means.
17. HELPLINE
A helpline is available, Monday to Friday.
Call: 01372 72 34 34
Or Email: [email protected]
18. TROUBLESHOOTING
If the unit does not work:
• No display - change batteries and ensure that they are
inserted correctly. Check battery springs.
• Controls won’t work
- If LOCK is shown on display. Hold Lock button on side for
three secs.
- No LOCK showing. Remove and replace batteries.
• No sensation and LEADS alarm showing.
Check lead and probe connection:-
- Dampen your hand with water and a little table salt. Squeeze
the probe firmly and carefully increase strength until you can
feel something or LEADS alarm shows.
- If you can’t feel anything, either lead or unit is faulty
- If you can feel something on your hand, and the LEAD alarm
does not show, then there is nothing wrong with the unit
or lead.

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The electrical conductivity of the vagina varies widely. The LEAD
detection circuit in the product is there as a safety feature. It
ensures that rapid changes in connection cannot cause very
uncomfortable rapid changes in stimulation. Unfortunately this
means that some users, who fall outside of the general range, may
experience unwanted LEAD alarms.
If this happens to include you, you can try;-
i) Using a water–based lubricant, which will improve conduction
ii) Crossing your legs and squeezing to increase pressure on the
probe, which should improve the connection. If this enables you to
use the unit, you should find that in a few weeks of stimulation the
contact improves. If it does not, then we are sorry to say that the
unit will not work for you.
iii) The probe supplied with the unit has a 28mm diameter. An
optional 32mm probe, part no X-VPM, is available.
• No sensation and no LEADS alarm
- If you have tried the test above and DO have sensation when
the probe is in your hand, then you may have reduced
sensitivity due to previously damaged or desensitised
pudendal nerves (this can happen in childbirth or some
surgical procedures).
• No sensation on one side
- The current flows from one side of the probe to other, so it is
not possible to have one side “not working”. However, the
strength of the sensation depends on how close to the nerve
the current flows, and also in which direction it flows relative
to the nerve. You can try slightly adjusting the position on the
probe, or exchanging the connection of the wires in the probe.

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19. CONSUMABLES AND SERVICING
PART NUMBER
X-VP Liberty Vaginal probe 28mm
X-VPM Liberty Plus Vaginal Probe 32mm
L-IT1 Replacement lead
X-AP Anal probe
X-PR13 Small diameter probe
E-CM5050 Electrode pads 50x50mm
K-GO Go Gel Personal Lubricant
These consumables can be purchased either from your supplier
or by contacting TensCare on 01372 723434 or by going online
to www.tenscare.co.uk. Please ensure that you order the correct
part number.
For servicing please call Tenscare on 01372 72 34 34 to discuss
the problem.
If your unit needs to be returned please send it to the Service
Department, TensCare Ltd, 9, Blenheim Road, Epsom KT19 9BE.
Please ensure that you enclose your name, address and contact
telephone number so that you can be contacted and informed
about any problem and any costs involved.
20. GUARANTEE
Your “itouch Sure” is guaranteed for two years from the date of
purchase. If a fault develops contact your dealer or Tenscare.
The guarantee does not cover probe, pads (optional extra),
batteries, or the mono lead wire.
Please note that the Guarantee is invalidated if:
i) incorrect batteries have been fitted
ii) if the unit has been immersed in water, maltreated or
tampered with.

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21. DISPOSAL OF WASTE ELECTRICAL
AND ELECTRONIC PRODUCTS (WEEE)
One of the provisions of the European Directive 2002/96/CE is that
anything electrical or electronic should not be treated as domestic
waste and simply thrown away. To remind you of this Directive all
affected products are now being marked with a crossed-out wheelie
bin symbol, as depicted below.
To comply with the Directive you can return your old electro-
therapy unit to us for disposal. Simply print a postage-paid
PACKETPOST RETURNS label from our website www.tenscare.co.uk,
attach this to an envelope or padded bag with the unit enclosed,
and post it back to us. Upon receipt we will send your old device for
components recovery and recycling to help to conserve the world’s
resources and minimise any adverse effects on the environment.
22. GENERAL SPECIFICATION
Max Intensity 50V zero to peak Constant voltage over 470-1500 Ohm
Constant current over160-470 Ohm
Channels single
Waveform Asymmetrical rectangular
Max Pulse energy * Total output limited to 25uC per pulse
Power 2 x AA Alkaline OR 2 x AA NiMH
Battery life At least 15 hours at 50mA 300uS 50Hz
Adjustable Timer - 10, 20, 30 45, 60, 90 min Defaults to 20 min
Pause button “Clock” key when running
Output plug Fully shielded: touch proof mini USB
Weight 90 gms without batteries
Dimensions 102 x 53 x 30mm
Safety Classification Internal power source.
Type BF Designed for continuous use. IP22
Environmental Specifications:
Operating;
Temperature range: 10 to 35C
Humidity: 20 to 93% RH
Atmospheric Pressure: 700hPa to 1060hPa
Storage:
Temperature range: -20 to +70C
Humidity: 93% RH non condensing
Atmospheric Pressure: 700hPa to 1060hPa
Typical operation time: No less than 1 week @ 50% AMP, 4 hours per day
TYPE BF Equipment providing a degree of protection against
EQUIPMENT electric shock, with isolated applied part.
This symbol on the unit means “Refer to Instructions for use”
The unit is not water resistant, and should be protected from liquids.
Expected Service Life The machine will often last for more than 5 years, but is
guaranteed for 2 years. Accessories (leads, pads, and batteries)
are not covered by the guarantee.
• Lead life depends greatly on use. Always handle the leads with care.
• Replace the probe every six months to ensure hygiene.
• Optional electrode pads should last 12-20 applications,
depending on skin condition and humidity.
• AA Alkaline Batteries should last about 18 hours continuous use.
Storage life • Storage life of an unopened pack of electrodes is 2 years.
This may be affected by very high temperatures or very low humidity.
• Storage life of batteries is 3 years.
• The unit and probe have no fixed shelf life.

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23. ELECTROMAGNETIC INTERFERENCE
Use special precautions regarding EMC according to the information
provided below.
• Other portable and mobile RF communications equipment can
affect performance.
• Do not use when adjacent to or stacked with other
electrical equipment.
• Use of leads or probes other than those listed in section 18
may affect EMC performance.
22. GENERAL SPECIFICATION (cont)
PROGRAM SETTINGS
Prog Hz Pulse Ramp Plateau Off Default
Width Up & (Sec) (Sec) Program
(uS) Down Duration
(Sec) (Min)
STRES 50 300 1 5 10 20
URGE 10 200 1 5 10 20
MIXED 20 250 2 5 10 20
TONE 35 250 2 3 6 20
Guidance and manufacturer’s declaration - electromagnetic emissions
The itouch Sure is intended for use in the electromagnetic environment specified below.
The customer or the user of the itouch sure should assure that it is used in such an environment.
Emissions test Compliance Electromagnatic environment - guidance
RF emissions Group 1 The model itouch Sure uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions Class B The model itouch Sure is suitable for used in domestic
CISPR 11 establishment and in establishment directly connected
to Harmonic emissions a low voltage power supply
Harmonic emissions Not applicable network which supplies buildings used for domestic
IEC61000-3-2 purposes.
Voltage fluctuations/ Not applicable
flicker emissions
IEC 61000-3-3
The Itouch Sure is intended for use in the electromagnetic environment specified below. The
customer or the user of the Itouch Sure should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or
discharge (ESD) ±8 kV air ±8 kV air ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative
humidity should be at least 30 %.
Electrical fast ±2 kV for power supply Not applicable Not applicable
transient/burst lines
IEC 61000-4-4 ±1 kV for Input/output lines
Surge ±1 kV differential mode Not applicable Not applicable
IEC 61000-4-5 ±2 kV common mode
Voltage dips, short <5 % UT (>95 % dip in Not applicable Not applicable
interruptions and UT) for 0,5 cycle
voltage variations 40 % UT(60 % dip in
on power supply UT ) for 5 cycles
input lines 70 %UT (30 % dip in
IEC 61000-4-11 UT )for 25 cycles
<5 % UT (>95 % dip
in UT ) For 5s
Power frequency 3 A/m Not applicable Not applicable
(50/60 Hz) magnetic
field IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level

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The Itouch Sure is intended for use in the electromagnetic environment specified below.
The customer or the user of the Itouch Sure should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance
Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m 3 V/m
IEC 61000-4-3 80 MHz to 2,5 GHz
Recommended separation distances between portable and mobile RF communications
equipment and the itouch Sure
The model itouch is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the model itouch Sure can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the model itouch Sure as recommended below, according to the maximum output power of
the communications equipment.
Portable and mobile RF
communications equipment should
be used no closer to any part of
the model itouch, including cables,
than the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter
Recommended separation distance
3V
d = 1.2√ P 80M Hz to 800MHz
d = 2.3√ P 800MHz to 2.5GHz
where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,
should be less than the compliance
level in each frequency range.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
Rated maximum
output power of
transmitter W
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may
not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the model itouch is used exceeds the applicable RF compliance level above, the model
itouch should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the model itouch.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Separation distance according to frequency of transmitter M
150kHz to 80MHz 80 MHz to 800 MHz 800MHz to 2.5GHz
d=1.2√ P d=1.2√ P d=2.3√ P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23