Body Clock iTENS User manual

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User Manual

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Contents
Contraindications, Precautions and Warnings ...........................3
Operating the iTENS ....................................................................6
Pack Contents ..............................................................................6
Button Description on the App ....................................................7
Setting Up Your Unit .....................................................................8
The Programs Folder .................................................................. 10
Commencing Treatment .............................................................11
The Documents Folder ............................................................... 13
The Settings Folder .................................................................... 14
Other Features ............................................................................ 15
FAQ’s and Troubleshooting ....................................................... 16
Body Diagram and Condition Program Parameters ............... 17
Specifications ............................................................................. 18
iTENS - EMC Information ...........................................................20
Explanation of Symbols on Unit
Equipment providing a particular degree of protection
against electric shock particularly regarding allowable
leakage currents having an F type (floating) applied part.
Warning - refer to page 3-5 of these instructions.
Please keep device away from sprays of water or rain.
The first number 2: Protected against access to
hazardous parts with a finger, and the jointed test finger
of 12mmø, 80mm length, shall have adequate clearance
from hazardous parts, and protected against solid
foreign objects of 12.5mmø and greater.
The second number 2: Protected against vertically
falling water drops when enclosure tilted up to 15°.
Vertically falling drops shall have no harmful effects
when the enclosure is titled at any angle up to 15° on
either side of the vertical.
Denotes a product which must be disposed of safely.
This symbol indicates the serial number of the device
and includes the year of manufacture. The serial number
can be found on the base of the charging station.
IP22
SN
This unit needs special precautions regarding EMC
and needs to be installed and put into service
according to the EMC information as found on
pages 20 - 23 of this manual.

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Foreword
Read this manual before using your iTENS device.
Body Clock strongly recommends carefully reading
the Contraindications, Precautions and Warnings and
subsequent chapters of this manual before use.
Contraindications:
1. Do NOT use this device
if you have a cardiac
pacemaker, implanted
defibrillator, or other
implanted metallic or
electronic device.
2. Do NOT apply
stimulation across
your chest because the
introduction of electrical
current into the chest
may cause rhythm
disturbances to your
heart, which could be
lethal;
3. Do NOT the iTENS
device during pregnancy
unless under medical
supervision.
4. Since the effects of
stimulation of the
brain are unknown, do
NOT apply stimulation
across your head, and
electrodes should not
be placed on opposite
sides of your head.
5. Do NOT place electrodes
on the front or side of
the neck because this
could cause severe
muscle spasms resulting
in closure of your airway,
difficulty in breathing,
or adverse effects on
heart rhythm or blood
pressure.
6. If you are in the care of a
physician, consult your
physician before using
this device.
7. If your pain does not
improve, becomes more
than mild, or continues
for more than five
days, stop using the
device and consult your
physician.
8. If you suffer from any
undiagnosed pain, have
any metal implants or
any doubts whatsoever
do NOT use the iTENS
and consult your
medical adviser.
9. Never use TENS to mask
undiagnosed pain as
this could require urgent
treatment.
General Precautions &
Adverse Reactions
1. Do NOT use this unit
without first reading
these instructions.
2. Do NOT immerse the
iTENS in any liquid
and do NOT apply
stimulation when in the
bath or shower.
3. Do NOT place it close to
any source of excessive
heat or operate it in the
presence of flammable
gas.
4. Do NOT drop this unit
onto a hard surface.
5. Do NOT attempt to
dismantle the iTENS.
6. Only use the specified
charger unit and gel
electrodes.

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7. If damaged, do not use.
Return to supplier.
8. Switch off the unit when
not in use.
9. Do NOT apply
stimulation while
sleeping.
10. Do NOT use while
driving or operating
potentially dangerous
machinery or during
any activity in which
electrical stimulation
can put you at risk of
injury.
11. Do NOT use in close
proximity (e.g. 1m) to
shortwave or microwave
therapy equipment to
avoid instability in the
stimulator output.
12. Do NOT apply
stimulation in the
presence of electronic
monitoring equipment
(such as ECG monitors
and ECG alarms), which
may not operate properly
when TENS is in use.
Portable and mobile
RF communications
equipment can affect
medical electrical
equipment. Operation of
the equipment or system
below this amplitude
or value may cause
inaccurate results.
13. Do NOT use adjacent to
or stacked with other
equipment.
14. Do NOT use the device
on children, if it has
not been evaluated for
paediatric use.
16. Do NOT place electrodes
across the head, directly
or near the eyes,
covering the mouth,
on the front or sides
of the neck (especially
the carotid sinus), on
the chest and upper
back so as to cross over
the heart, directly over
your heart or an area
of broken, inflamed,
infected or numb skin.
17. The gel electrodes
should only be applied
to skin with normal
sensation unless under
medical supervision
since skin irritation
could occur following
long term application.
18. Do not apply stimulation
over, or in proximity to,
cancerous lesions.
19. If you have suspected
or diagnosed
epilepsy, you should
follow precautions
recommended by your
physician.
20. Use caution if you have
a tendency to bleed
internally, such as
following an injury or
fracture.
21. Consult with your
physician prior to using
the device after a recent
surgical procedure,
because stimulation
may disrupt the healing
process.
22. This is an internally
powered medical
electrical equipment.
Do not use power
sources other than
those specified in these
instructions.

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Warnings
1. Mild temporary
skin irritation can
occur following long
term application.
Simultaneous connection
by the user to a high
frequency surgical
medical electrical
equipment may result
in burns at the site of
the electrodes and
equipment. Users should
seek advice from their
medical advisors when
use of this equipment is
required.
2. Ensure that the device
and all accessories are
stored away safely out
of the reach of children
and babies at all times.
Keep out of the reach of
children and babies.
3. It is unsafe to use
accessories, detachable
parts and materials
not described in these
instructions for use.
Please see
www.bodyclock.co.uk
for suitable accessories
or contact us if you
require any spare parts
on [phone].
4. Do NOT interconnect this
device with any other
equipment not described
in these instructions for
use.
5. Do not modify this
equipment in any way.
6. The iTENS is not user
repairable and must
be returned to the
manufacturer if it requires
repair.
7. This unit needs special
precautions regarding
EMC and needs to be
installed and put into
service according to
the EMC information
provided on page 20.
If you have any concerns
please do not hesitate
to contact Body Clock
Health Care Ltd on
[phone] or
at [email protected]
Environmental
Conditions
• Operating Temperature:
+00C to +400C
• Operating Humidity:
10%R.H to 93%R.H
• Operating Atmospheric
Pressure:
700 hPa to 1060 hPa
• Storage/Transport
Temperature:
-250C to +700C
• Storage/Transport
Humidity: 8% to 93%
R.H

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Instructions for Use
Your iTENS is simple to use and offers a wide variety
of settings ideal for acute and chronic pain relief.
Pack Contents
Your iTENS pack should contain the following:
Having checked that all of the contents are present and
correct, please proceed to assemble the unit.
• 1 x iTENS device
• 2 x Peel-n-Stick Adhesive
Gel Pads
• 1 x Resealable poly bag for
storing electrode wings
• 1 x Set of iTENS electrode
wings
• 1 x iTENS charging station
• 1 x iTENS USB charging
cable
• Quick Start Guide
• User Manual

7
Operating the iTENS
On-device settings:
The area above
and below the
centre button is
used for intensity
increase/decrease.
However, the
intensity is mainly
adjusted via the
iTENS App.
Press and hold
down the centre
button for more
than 3 seconds
to turn the iTENS
either ON or OFF.
Button Description on the App
Intensity
Decrease
To lock/
unlock all
device and
App screen
settings
Shows how
many iTENS
units are
connected to
the App. In this
case it is ‘1’
Home Screen
Program
Settings
Adds
programs
to your
favorites
If grey,
indicates it is
disconnected.
If blue
indicates that
the device is
connected
to the
smartphone
or tablet.
Settings
Folder
Documents
Folder
Intensity
Increase
Intensity
Increase
Intensity
Decrease

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Setting Up Your Unit
1. Remove the iTENS device from electrode wing and snap
it into the charging station ensuring that the contacts
align on each.
2. Charge the device for 2.5 hours before use by plugging
the charging cable into the charging station and a
powered USB socket (either via a computer or other
suitable device). The iTENS device will flash whilst
charging.
3. The iTENS device will stop flashing once charged.
Remove it from the charging station and connect it back
to the electrode wing by snapping it into the holder.
4. Now apply the gel pads to the electrode wing by
peeling off one side of the gel pad film and applying
the gel pads to the silver space defined on the back
side of the wing. Leave the remaining piece of film
on each gel pad until the device is ready to use (see
diagram below).
5. Install and open the iTENS App on your smartphone or
tablet. The iTENS App is available from the Apple App
Store and Google Play Store under the name “iTENS”.
6. Once the App is installed, you are ready to use your
iTENS device.
Press and hold the center button on the iTENS device
for 3 seconds (see diagram on page 7). This will
initiate the connection between your iTENS device
and the App. This is also known as ‘Pairing’.
The LED light will begin flashing on the iTENS device
which means that the connection mode is active.
Remove pads from the pouch
and peel away one side of
protective film from the gel.
Place exposed gel face down onto
the silver underside of the wing so it
is aligned and flush with the wing.

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N.B Bluetooth must be turned on in your smartphone
or tablet settings to pair with iTENS device.
7. The first screen you will see on the App
is the Home Screen (see page 7).
This is indicated by the small ‘HOUSE’
sign at the bottom of the screen.
Press the ‘broken’ chain link icon on the
Home Screen to search and pair with all
available iTENS devices. Initially this icon
link will be greyed out.
8. The next screen will enable you to
choose the iTENS device you wish to
connect to your smartphone or tablet.
It will initially be named: ‘Unknown
Device’. You can rename this later (see page 14).
Select this option to commence the pairing process.
9. A solid blue light showing on the button of the
iTENS device.
You will automatically be returned
to the Home Screen of the App
which will now show a ‘complete’
chain icon and it will be coloured
blue.
The ‘ON’ button will also be
highlighted in blue.
N.B the iTENS device is capable of
connecting up to 4 devices at one time.
Each number at the bottom of the Home Screen
represents how many devices are connected to your
smartphone or tablet (see page 7).
10. Your device is now ready to use. Before removing the
remaining layer of film on the electrodes from the
electrode wing, you will need to choose your desired
treatment and pad placement. This can be done in
four ways on your iTENS device.
The ‘THE PROGRAMS FOLDER’ section will describe
how to do this (see page 10).

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THE PROGRAMS FOLDER
Access the treatment programs in your App by pressing
the ‘head and shoulders’ symbol at the bottom of the
Home Screen. All unused symbols are dark purple.
When in use they become white. From here you can
select one of the following four settings:
i) ‘Body Part’ - for specific
body part treatments
ii) ‘Condition’ - select
treatment based on
your specific pain
condition
iii) ‘Manual Mode’ - to
create a custom setting
iv) ‘Favourite’ - saves your
favourite setting(s),
which you can name
and access from the
‘star’ symbol on the
Home Screen (see page
13 for more details)
It is highly recommended to experiment with the
different settings to find your optimal program.
i) Body Part 
Once selected, this mode
enables you to choose a
TENS treatment program
associated with 11 different
body parts (see page 17 for
a list of these).
Simply scroll to your
preferred body part by
using the arrows on the
screen and press ‘Select
Program’. This will return
you to the Home Screen
where you can commence
treatment.

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Commencing Treatment
Now remove the extra layer of film on the sticky pads of
your iTENS device and attach it to the desired body part.
Retain the film for storage.
Commence your treatment
by increasing the intensity +
button. Decrease the intensity
by pressing the - button.
As you increase the intensity, you will feel
a mild tingling sensation. Adjust intensity
to a level that is comfortable but not overpowering.
N.B Each of the 11 ‘Body Part’ programs have different
treatment times. Please refer to page 17 for a list of
these.
ii) Condition Mode 
Once selected, this mode
enables you to choose a
TENS treatment program
associated with 15 different
pain conditions (see page
13 for a list of conditions
and treatment times).
Now follow the
‘Commencing Treatment’
section as above.

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iii) Manual Mode 
This mode enables you
to create a specific TENS
setting where you can
adjust the Pulse Rate, Pulse
Width, the Waveforms and
Treatment Time according
to your requirements.
Manual mode settings
B - stands for Burst
Mode (a rise and fall
of impulses. Typically
used for short term
therapy sessions)
C - stands for Continuous
Mode (a constant
level of impulses.
Typically used for short or long term therapy
sessions)
M - stands for Modulation Mode (a ratio of impulses
such that your body doesn’t adjust to the stimuli.
Typically used for long term therapy sessions)
Pulse Width - increases the space between each wave.
Pulse Rate - increases the frequency in which the
waves travel through the skin. Typically
the higher, the more comfortable the
stimuli.
Wave Form - addresses different main conditions
in more effective manners, e.g. mono-
phasic wave is best for pain in the
extremities.
Timer: Chooses between 15, 30, 45, 60 and continuous
minutes.
Once you have selected your parameters by choosing
them on the screen press ‘Select Program’.
You will now return the Home Screen.
N.B Review page 18 for a more detailed explanation of
these parameters.
Now follow the ‘Commencing Treatment’ section as
found on page 11.

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iv) Favourite Mode 
At any time you can save
your favourite treatment
via the home page, by
pressing the ‘STAR’ button.
Once pressed you can
type and save the name of
this program, which can
be accessed at any time
from the ‘Favourite’ Mode
as found in the Programs
section of the app (see
page 10).
Once you have selected
your ‘Favourite’ program,
follow ‘Commencing
Treatment’ section as found on page 11.
N.B Initial treatments should last for around 30 minutes,
and for some people it may take 3-4 therapy sessions
over the first couple days of use, for the body to
acclimatise to electrotherapy. You should experiment
with your settings and placement of the wings to find
the optimal treatment settings.
THE DOCUMENTS FOLDER
This can be accessed by pressing the ‘book’ symbol at
the bottom of the App. This
contains the Quick Start
Guide, Full Instructions,
Privacy Statement,
EULA (End User License
Agreement) and Electrode
Placement Chart.
It is recommended that
you view these to obtain
the most out of your iTENS
device.

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THE SETTINGS FOLDER
This can be accessed by pressing the ‘Cog’ symbol at the
bottom of the App.
i) Rename - This is where you can personalise the name
of your iTENS device. Select ‘Rename’ and type the
required name then press ‘OK’.
ii) Track cumulative usage time - You can view the
length of time you have used your device in this
section. To reset, press the ‘Reset’ button.
iii) Track your result - Here you can
enable or disable the “track your
results” settings.
By enabling this function, you
will be prompted to
enter your pain level
before and after your
treatment. You can
select this by sliding the
purple ball back and
forth to determine your
pain level for before and
after treatment.
iv) Chart your results - Here you can chart and record
your results and measure the benefit of using the
iTENS device.
Other data points regarding your therapy sessions will
begin to be tracked as well. Tracking can be disabled
whenever needed.
N.B There will no data initially.

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Other Features
1. When the intensity is set to zero or the iTENS has not
been used 30+ minutes, the device will automatically
shut down.
2. When the unit is turned on, it will automatically
remember the mode which was previously used.
3. When switching between programs, the output level
will automatically drop to zero.
4. When the treatment timer is set, it will begin to count
down one minute at a time. Once it counts down to
zero, the unit will automatically shut down.
5. When one or both electrodes are not placed firmly on
skin, or they become loose from the skin, the output
level will automatically drop to zero.
6. The selected program will only run when the intensity
is set above zero.
7. The iTENS App can operate in the background of your
phone or tablet enabling you to use it normally during
treatment
8. The treatment time will be accumulatively recorded
when the output level is above zero. Other track and
chart features need to be enabled in the settings
section of the App.
Gel Pads
The pads that are supplied with your iTENS device are
self-adhesive and can be used several times. Properly
maintained gel pads can last up to 15 times. Your
skin must be allowed to breathe, so the wings should
be removed from the body periodically. When not in
use, the pads can stay on the wings, covered with the
protective liners and should be placed into the clear
plastic poly bag, which should be resealed and kept
closed afterwards.
After Use
Always ensure that the unit is turned OFF and place the
iTENS wings into the resealable poly bag provided.

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FAQ’s:
Q Are there any side effects?
A No, it is totally drug free. There are no known side
effects.
Q Can I use it with other medications?
A Yes. TENS is drug-free so you can use it with any
other medication including paracetamol and
ibuprofen.
Troubleshooting
Q Why does the pulse sensation not appear to be as
strong after you have used the iTENS for a while?
A Increase the intensity, you may have become
acclimatised to a lower setting.
Q Why does the pulse sensation feel strong but
ineffective?
A You may need to reposition the gel pads (don’t forget
to switch the iTENS off before doing so).
Q What should I do if I can not feel any or little
sensation even on a high intensity setting?
A Check that the gel pads are fixed to the skin and also
check that the unit is charged. Check if the gel pads
need replacing.
Q There appears to be a small amount of
discolouration on my electrode wing. Is there
something wrong?
A No, this is perfectly normal. You may notice some
small brown specks appearing on your electrode
wing over time. It is a reaction which may occur
between the electrode wing, the sticky pads and
the natural oils found in your body. This will not
diminish the effectiveness of the TENS stimulation.
However, please be aware that the electrode wing is a
consumable item and should be replaced up to every
six months if used regularly.

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Body Diagram Parameters - used to treat specific areas of the body.
All parameters are pre-programmed, except for the intensity. The Body
Part program has 11 different types of treatment parameters as follow:
NO. Program Frequency
(Hz)
Pulse width
(uS)
Total time
(min)
1Wrist pain 100 50 30
2Elbow pain 1-100 50-300 25
3Shoulder pain 4200 30
4Quadriceps 2-150 50-250 40
5Mid/upper back pain 2-120 100-250 40
6Low back pain 2-100 75-250 40
7Abdominal cramping 2-30 100 25
8Hip pain 2-80 100-150 30
9Knee pain 5-150 50-150 25
10 Ankle pain 5-150 50-200 30
11 Hand/foot pain 2-150 200 30
Condition Program Parameters - used to treat based a specific pain
condition with a pre-set modes except for the intensity level which is
adjustable. The Conditions program has 15 different types of treatment
parameters as follows:
NO. Program Frequency
(Hz)
Pulse width
(uS)
Total time
(min)
1Acute pain 3-100 50 30
2Chronic pain 2-70 100-250 35
3Muscle spasm relief 3-25 200 30
4Muscle rehabitation 1-25 200 35
5Muscle stimulation 3-60 340 30
6Sciatica 2-150 50-250 20
7Epicondylitis 1-100 50-300 25
8Post surgical pain 50-150 50-250 20
9Neuropathy pain 1-120 50-100 30
10 Bursitis 70 150 60
11 Osteoarthritis 100 200 60
12 Rheumatoid Arthritis 70 200 60
13 Carpel Tunnel 5-100 50-200 20
14 Fibromyalgia 2-100 75-250 40
15 Tendonitis 1-100 50-300 25

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Detailed information regarding the Waveform, Pulse
Width, Pulse frequency, and Output voltage range.
A. Waveform
There are 3 types of waveforms - adjustable in manual
modes.
1. Symmetrical Bi-Phasic rectangular waveform
Amplitude
Time
Amplitude
Time
2. Asymmetrical Bi-Phasic rectangular waveform
Amplitude
Time
3. Mono-Phasic waveform
Specifications

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B. Pulse Width - adjustable in manual mode.
By clicking area above and below the center button,
or +/- in the app, the pulse width can be adjusted
from 50μS to 250μS in step of 10μS.
C. Pulse Frequency - adjustable in manual mode.
By clicking area above and below the center button,
or +/- in the app, the pulse frequency can be adjusted
to one of the following values (Hz):
1, 2, 3, 4, 5, 10, 12, 14, 16, 18, 20, 25,30, 35, 40, 45,
50, 60, 70, 75, 80, 90,100, 110, 120, 130, 140, 150.
D. Output Voltage Range - adjustable in all modes.
Specifications continued
Model: iTENS
Channel: Single
Output: Maximum 130 mA (peak value) across
500 Ohm load
Pulse Width: From 50μS to 250μS adjustable
Pulse rate: From 1Hz to 150Hz adjustable
Waveform: Symmetrical Bi-phasic rectangular
Asymmetrical Bi-phasic rectangular
Monophasic rectangular
Treatment timer: 15, 30, 45, 60min, unlimited
Mode: Body Diagram Conditions Manual mode

20
1) * This product needs special precautions regarding EMC and
needs to be installed and put into service according to the
EMC information provided, and this unit can be affected by
portable and mobile RF communications equipment.
2) * Do not use a mobile phone or other devices that emit
electromagnetic fields, near the unit. This may result in
incorrect operation of the unit.
3) Caution: This unit has been thoroughly tested and
inspected to assure proper performance and operation!
4) * Caution: this machine should not be used adjacent to or
stacked with other equipment and that if adjacent or stacked
use is necessary, this machine should be observed to verify
normal operation in the configuration in which it will be
used.
Guidance and manufacturer’s declaration – electromagnetic emission
The iTENS is intended for use in the electromagnetic environment
specified below. The customer of the user of the iTENS should
assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment
– guidance
RF emissions
CISPR 11
Group 1 The iTENS use RF energy
only for its internal function.
Therefore, its RF emissions
are very low and are not likely
to cause any interference in
nearby electronic equipment.
RF emission
CISPR 11
Class B The iTENS is suitable for use in
all establishments, including
domestic establishments and
those directly connected to
the public low-voltage power
supply network that supplies
buildings used for domestic
purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Complies
iTENS - EMC Information