Tens i-Pulz 2 User manual

USER MANUAL
i-Pulz 2

Read this manual carefully before using the
i-Pulz 2 and keep closely to the instructions
of your treatment specialist.
Table of contents
1 Device information ........................................................................4
Intended purpose ...........................................................................4
Intended patient population ...........................................................4
Indications ................................................................................4
Contra-indications ....................................................................4
Intended parts of the body.............................................................5
Side effects.....................................................................................5
Environment....................................................................................6
Warnings.........................................................................................6
Precautions.....................................................................................6
Maintenance...................................................................................7
IP rating ..........................................................................................8
2 The i-Pulz 2 nerve stimulator ........................................................8
General ...........................................................................................8
Controls ..........................................................................................8
Buttons ...........................................................................................9
The display ...................................................................................10
Indication LED ..............................................................................11
Channels left and right .................................................................11
3 Starting the treatment .................................................................11
Cleansing of the skin ....................................................................12
Placing the electrodes..................................................................12
Setting up the stimulator ..............................................................12
Treatment period ..........................................................................13
Stopping the treatment.................................................................14
Removing the electrodes..............................................................14
Taking care of your skin................................................................14
Irritation of the skin.......................................................................15
4 Settings menu and advanced possibilities ................................15

Settings menu ..............................................................................15
Adjust menu .................................................................................17
Low and rest intensity.............................................................19
Compliance menu ........................................................................19
Controls ..................................................................................20
Charging .......................................................................................21
5 Accessories .................................................................................21
Cables ..........................................................................................21
Electrodes available separately....................................................21
Wireless charger...........................................................................21
6 Optional Wearables .....................................................................22
7 Contents of package ...................................................................22
8 Technical information ..................................................................22
9 Pre-set overview..........................................................................24
10 Errors............................................................................................26
Error-numbers...............................................................................26
Other indications/faults ................................................................27
Irritated skin..................................................................................29
11 Important information regarding EMC........................................29
General .........................................................................................29
Table 1 Emissions Guidance for users .........................................30
Table 2 Immunity Guidance for Users ..........................................31
Table 3 Conducted and Radiated Immunity Guidance ................32
Table 4 Recommended separation distance................................34
i-Pulz2_UserManual_EN_V1.2.pdf 4-2020

4 i-Pulz 2
1 Device information
Intended purpose
The i-Pulz 2 is intended for transcutaneous electrical nerve stimulation
(non-invasive nerve stimulation). A treating specialist can prescribe
treatment with the i-Pulz 2 to treat acute and chronic pain complaints
and syndromes. See the indications.
Intended patient population
The i-Pulz 2 may be used on all patients with a minimum age of
approximately 15 till +99 years indicated for transcutaneous electrical
nerve and/or muscle stimulation by a qualied pain treatment
specialist. Children under the supervision of the parents.
Indications
Typical prescriptions for use by qualied pain treatment specialist are:
• Neurological pain, like neuralgia, blunt pain and phantom pain.
• Muscle and joint pain, like rheumatic pain, lower-back pain, neck
and shoulder pain, etc.
• Post-surgery and post-traumatic pain.
• Angina Pectoris.
• Facial pain.
• Delivery pain.
• Complex Regional Pain Syndrome, CRPS type I and II.
• Scar tissue pain.
• Muscle treatment.
Contra-indications
Patients* with:
• Skin conditions or damaged skin.
• Implanted electronic device, for example, a cardiac pacemaker or
implantable cardioverter-debrillators.
• Metal implants.
• Tumours or malignant activity.
• Cardiac arrhythmia.
• Epilepsy.
• Pregnancy (especially the first 12 weeks).
• Reduced awareness.
• Dementia.

5i-Pulz 2
• Cognitive limitation and/or not independent in “ADL” in
combination with insufcient help from third parties.
* The qualied pain treatment specialist must determine eligibility for
transcutaneous electrical nerve stimulation.
Intended parts of the body
Within the specied use cases electrode placement is prohibited for
the following parts of the body*:
• On damaged or irritated skin/tissues.
• Across or through the head (Trans cerebrally).
• Directly on the eyes.
• Covering the mouth or the lips.
• On the front of the neck (especially the carotid sinus).
• Crossing the heart section.
• From electrodes placed on the chest and the upper back (through
the chest using an anterior and posterior electrode positions, or
other transthoracic applications understood as “across a thoracic
diameter”).
• Application of electrodes near the thorax may increase the risk of
cardiac brillation.
• Directly over the spinal column.
* The qualied pain treatment specialist must determine eligibility for
transcutaneous electrical nerve stimulation.
Side effects
Electrical stimulation can cause buzzing, tingling, or prickling
sensations.
See the packaging or leaet of the electrode for the used materials.
Electrodes, gel or patches can cause an allergic reaction,
including that of the skin.

6 i-Pulz 2
Environment
The i-Pulz 2 is a non-sterile device which does not require a sterile
environment. It is a battery-powered, portable device that is suitable
for home use, which makes the patient the intended operator. The
i-Pulz 2 is suitable for outdoor use within the specied conditions.
A treatment must be interrupted when driving or controlling heavy
machinery.
Warnings
• Simultaneous use of the i-Pulz 2 and surgical devices operating on
a high frequency can cause burns where the electrodes are placed
on the skin.
• The operation of electronic monitors, like ECG equipment, can be
disrupted when the i-Pulz 2 is activated.
• Never use the i-Pulz 2 for purposes not described in this manual.
• The use of the i-Pulz 2 in the range of shortwave or microwave
equipment (cellular phone or microwave) can cause uctuations in
the output of the i-Pulz 2.
• Do not use electrodes with a smaller surface than 15 cm² as this
can cause skin irritation or even burns.
• Irritation of the skin can be caused by “lengthy” use of small
electrodes and/or an electric current that is too high.
• Keep the i-Pulz 2 out of reach from children.
• Only use the i-Pulz 2 on the advice of a medical specialist; never
lend out your TENS device.
Precautions
• Please make sure the i-Pulz 2 doesn’t get hit, fall or is used
inappropriately to avoid it getting damaged.
• Check the i-Pulz 2 and cables for any inconsistencies before using
it. Do not use if damaged or degraded in any way and replace the
device or cable immediately.
• Avoid connecting the device to other equipment not described
in this manual as this may make the device unsafe for use or
compromise the selected therapy.
• Always check if the i-Pulz 2 is switched off before removing or
placing electrodes.
• While it is not necessary to store the i-Pulz 2 in its carry case when
not being in use or when being transported, it is advisable to do

7i-Pulz 2
so for safety and added protection from dust, pet hairs, pests or
insects, and so on.
• Remove the device from its carry case when intending to use it.
• Only use the i-Pulz2 device with accessories supplied as alternative
accessories may make the device unsafe or compromise the
selected therapy.
• Do not wrap cables around the neck as this could lead to serious
injury or strangulation.
• Do not connect electrode cables to other devices or objects.
• Keep the device away from heat sources, which can damage the
internal battery.
Maintenance
The i-Pulz 2 stimulator requires little to no maintenance.
• If needed, clean the device with a damp cloth. Make sure the
device is OFF and never use aggressive detergents and solvents
like ether, alcohol, or abrasives.
• Never submerge the device in water or in any other liquid. In case it
does get submerged, get the device checked by the manufacturer
or distributor before you use the i-Pulz 2 again.
• You can clean the cables with a damp cloth. The use of aggressive
detergents is not advised, because the cables can get damaged or
become rigid, which increases the likelihood of the cables breaking.
• If the i-Pulz 2 is to be used on multiple patients, then it is necessary
to use new cables and electrodes each time. Professional hygienic
maintenance prior to re-use is not required for the i-Pulz 2 device
itself.
• The expected service life of the i-Pulz 2 is ve years, though this
strongly depends on its use. The manufacturer advises a technical
check-up of the device every 5 years.
• Servicing and maintenance are not permitted while the i-Pulz 2 is in
use.

8 i-Pulz 2
Only the manufacturer or distributor should do repairs or
upgrades to your i-Pulz 2. Never modify the device. Contact
your distributor for more information.
Information from the manufacturer and distributor can be found on the
back of this user manual.
IP rating
The i-Pulz 2 is classied with an ingress protection rating IP22. This
means that the device is protected from touch by ngers or similar
objects greater than 12,5 mm and is effective against condensation.
2 The i-Pulz 2 nerve stimulator
General
The i-Pulz 2 is a two-channel nerve stimulator. There is a channel
on the left- and right side of the device. Both channels work
independently from each other and do not inuence each other – two
different forms of stimulation can, therefore, be used simultaneously. It
is also possible to use only one channel.
The i-Pulz 2 has 12 standard stimulation pre-sets (indicated by P1 to
P12). It is also possible to adapt user specic pre-sets (indicated by
P13 to P15) and to mask them (render invisible). The masking option is
to simplify the use of the device. The i-Pulz 2 will always start with the
last used pre-set and, if set, the last used timer-function as well.
Controls
I-Pulz 2 makes use of touch-technology. The buttons required to
control the device are at the front of the device. At the top is a physical
Power button to turn the device ON/OFF.

9i-Pulz 2
Power button
Screen
Up/down, left
Timer
Up/down, right
Pre-set
Indicator LED
Channel, right
Channel, left
Buttons
Power button
Press this button to turn ON the
device. Hold the button pressed
for 2 seconds to turn it OFF. In
the case of an active pre-set
(intensity > 0 mA), it is possible
to enable or disable the key-
lock.
Pre-set
Pressing this button (once or
multiple times) will select a
pre-set. In the case of an active
pre-set (intensity > 0 mA), it is
possible to reduce the intensity
to 0 immediately by holding the
pre-set button pressed for 2
seconds.
Timer
Pressing this button enables you to set a timer for the pre-set. Press
the Timer button (once or multiple times) to set up the desired time
(ranging from 0 to 99 minutes and starts at 0 again). By holding the
Timer button pressed for 2 seconds, the timer will be turned OFF.
The timer icon in the upper left corner of the screen, which usually
indicates that the timer is activated, will disappear, and the timer value
will be - - - - . Timer adjustments can only be done if both channels are
set to 0 mA.
It is possible to enable or disable the pause-function by holding the
Timer button in case of an active pre-set (intensity > 0 mA).
Up/Down
Pressing these buttons allows you to control the intensity. The buttons
on the right-hand side of the device control the right-hand side
channel and vice versa. These buttons can also be used to set other
parameters of the device (see chapter 4).

10 i-Pulz 2
The display
A – Pre-set number /
(remaining) time
B – Keypad lock
C – Timer
D – Warning, check the user
manual
E – Battery indicator
F – Intensity display left
channel
G – Intensity display right
channel
H – Graphics section
A - Pre-set number / (remaining) time
The pre-set number will be displayed here. After setting the intensity,
the timer will countdown to 0 minutes (if activated). During the
treatment, it is possible to show the active pre-set or remaining time by
tapping on the pre-set or Timer button.
B – Keypad lock
If the buttons are not pressed after setting the intensity, the keypad
lock will activate after 15 seconds. This function prevents any
accidental increase in the intensity. The key-icon indicates that the lock
is active. The backlight will also dim when the lock is active. The key-
lock can be (de-)activated with the Power button.
C – Timer
When the clock-icon is visible, the timer is active.
D – Warning, check the user manual.
When this icon is displayed, please read the manual for further
instructions (see chapter 10).
E – Battery indicator
This icon indicates the capacity of the battery and is displayed in 5
steps (100%, 75%, 50%, 25%, <5%).
F – Intensity display left channel
The display shows the set intensity.
A D
B
C
FG
H
E

11i-Pulz 2
G – Intensity display right channel
The display shows the set intensity.
H – Graphics section
This section is used to clarify the pre-sets used. Every pre-set has a
graphic representation of the TENS waves being used. See chapter 4
for device options and other display menus.
Indication LED
The indication LED lights up during the charging-process or when an
error has occurred. See the section “Charging” or “Errors” for more
information.
Channels left and right
The channels are the outputs where the
cables for the electrodes can be connected.
The channel on the left side is the left channel,
the channel on the right side is the right
channel. When a channel is active, the socket
will light yellow. This indicates that a current is
owing through this channel to the electrodes.
Do not remove the cable or the electrode when active
as it could result in an electrical shock.
3 Starting the treatment
When using the device daily, these are the steps to follow:
• Cleansing of the skin
• Placing of the electrodes
• Setting up the stimulator
• Treatment active
• Stopping treatment
• Removing the electrodes
• Skincare

12 i-Pulz 2
Cleansing of the skin
It is important that you give the proper care to your skin. Cleansing
your skin properly will ensure good contact with the electrodes and will
help you to prevent irritation to the skin. Carefully clean your skin with
a mild soap. It is advised that you remove all body hair on the location
where the electrodes are to be placed, as they may cause irritation. To
ensure that the electrodes stick to your skin properly, please make sure
that your skin is not oily or greasy. Furthermore, with proper cleansing
the electrodes and patches will be easier to remove.
Placing the electrodes
Follow the instructions on the packaging of the electrodes or on their
instructions for use. Place and connect only one pair of electrodes at
the time, to avoid confusion.
Keep to the instructions of your treating specialist when
placing the electrodes.
Setting up the stimulator
After the electrodes are placed properly, you can activate the device.
The device starts up with the pre-set you used last. During the trial
period, you and your treating specialist have decided which pre-set(s)
is best suited for you. Chapter 9 gives an overview of all the standard
pre-sets.
Select pre-set
Every time you press the pre-set button the next pre-set will appear
(it is an ongoing list; you will reach your starting position eventually).
When holding the pre-set button for 2 seconds, it will switch back to
the last used pre-set.
Set timer
Check if the timer is set properly for the duration of the therapy. By
tapping on the Timer button the time increases. By holding the Timer
button for 2 seconds, the timer will be disabled.
Once the pre-set is started, this timer value will be saved and used
automatically when you select that pre-set again.

13i-Pulz 2
Set intensity
After you have selected the desired pre-set, you can set up its
intensity. Pressing the Up-button briey will increase the intensity in
small steps of 0,5 mA. When you keep the up-button pressed, the
intensity will increase faster.
Caution: for safety regulations, it is not possible to increase
the intensity beyond 20 mA when keeping the Up-button
pressed. Only when you release the button briefly can you
increase the intensity again, till the next “hold-point”:
20 – 40 – 60 – 70 – 75 – 80 – 85 – 90 – 95 – 100.
Keep to the maximum intensity indicated for the size of the
electrode in Chapter 10.
If there is none or a limited connection between
the device and your skin, and the intensity
comes above 5 mA, a warning sign and a cable
icon will be displayed. The intensity of the
relevant channel will be indicated by ”nc”. See
“Figure 1 no connection”.
When the intensity will be set higher than
7.5 mA, the device disables the channel to
prevent any hazards. See Figure 2 output
disabled.
In this case, check if the cables and the
electrodes are properly connected and if
necessary, replace them. Then retry to set the
intensity again. See the section “Error” for more
information.
Treatment period
Regarding the treatment period, you must strictly adhere to the
instructions from your doctor or pain treating specialist. If you need
a longer treatment period, you should discuss this with your treating
specialist before changing your stimulation patterns.
In consultation with your doctor, you can do exercises or contemporary
activities during the treatment.
Figure 1 no connection
Figure 2 output disabled

14 i-Pulz 2
Do not use the i-Pulz 2 when driving or controlling heavy
machinery and not in damp areas such as in the bathroom.
Pause
If it is desired to take a break during the treatment, hold the Timer
button pressed for 2 seconds. Then the intensity goes back to zero.
To resume the treatment again, press the Timer button again for 2
seconds, and the intensity gradually increases to the intensity level
before you paused.
Stopping the treatment
If the timer is activated, the i-Pulz 2 stimulator will switch off both
channels automatically when the timer is nished. The treatment can
also be stopped manually by holding the pre-set button pressed for
2 seconds. Or by turning down the intensity until it reaches 0.0 mA.
When the intensity reaches 0.0 mA, the device will switch off after a
few minutes in order to preserve the batteries. The device can also be
switched off by pressing the Power button.
Removing the electrodes
Always switch the device off before removing electrodes!
When removing the electrodes, follow the instructions on the
packaging of the electrodes or on their instructions for use.
Taking care of your skin
After you have removed the electrodes, you can carefully clean your
skin with a mild soap. Never use aggressive substances like ether or
alcohol to remove any adhesive residues.
After the skin is cleaned, a red mark from the patches and/or
electrodes may be visible on the skin. This reaction usually disappears
quickly.

15i-Pulz 2
Irritation of the skin
Despite all the precautions, it is possible that you experience irritation
of the skin. If you experience persistent irritation of your skin when
using the i-Pulz 2, please contact your treating specialist.
4 Settings menu and advanced possibilities
Settings menu
To open the settings menu, hold the Power button
pressed when the device is OFF. After 2 seconds,
the device switches to the settings menu. It starts
with device information, which indicates the
software version and PCB number.
By tapping on the pre-set button, it can step
through the menu items:
• Device information
• Cable tester
• Buzzer
• Time
• Timer step-size
• Mask pre-set
• Default settings.
To change the settings of the selected item, tap on
the Timer button.
Device information
This item pertains to specic information of the device like software
version and PCB number. This data may be requested by the
manufacturer or istributor if you report a defect or problem. By tapping
on the Timer button, it will display extra information about the battery.
SoC indicates the state of charge in % and SoH the state of health of
the battery.
Device
information
Cable tester
Buzzer
Time
Timer
step-size
Mask
preset
Default
settings

16 i-Pulz 2
Cable tester
Connect the supplied cable(s) to the device without connecting the
electrodes. For both channels, the text “OPEN” will be displayed on
the screen. You can now test the cable by pressing the 2 mm pins
together. The text on the display will change from “OPEN” to “CLOSE”
on the side of the device where you are testing the cables, you will also
hear a beep. If this is not the case, and the text “OPEN” remains on the
screen, this indicates that the cable is defective and must be replaced.
Please contact your distributor for a new set of cables.
With the Timer button, it is possible to leave this item and go back to
the settings menu again.
Buzzer
This option allows you to switch the sound that is heard by each touch
input on or off, to give extra feedback when a button is “pressed”.
With the left up-button, the sound will be turned off, with the right up-
button, the sound will be turned on. By pressing on the Timer button,
you will be asked if this change should be saved, before the device
goes back to the settings menu.
Time
The device stores the actual time, which
will be used for the compliance function. If
the time or date is not accurate, the other
functions of the device will still work correctly.
When you open this menu, the current
time and date will be displayed in the time-
overview. To change the time or date,
press the pre-set button to step through
the available values. With each value, is it
possible to decrease the value with the left
up-button and increase the value with the
right up-button.
By pressing the Timer button, it will switch
back to the time-overview.
When pressing on the Timer button in the
time-overview you will be asked if this change
should be saved, before the device will go
back to the settings menu.
Time
overview
Hours
Settings menu
Minutes
Year
Month
Day

17i-Pulz 2
Timer step-size
The timer step-size is set to 10 minutes by default. This interval size
can be changed to 1, 5, 10, or 15 minutes with the left or right up-
buttons. By pressing on the Timer button you will be asked if this
change should be saved, before the device will go back to the settings
menu.
Mask pre-set
With this menu item, it is possible to mask or unmask every pre-set.
This option can be active to simplify the use of the device by hiding
unused pre-sets.
With the pre-set button, it is possible to step through the pre-sets, with
the left or right up-button it is possible to mask/unmask the pre-set.
If all pre-sets are masked, P1 will remain visible during normal
use.
By pressing on the Timer button you will be asked if this change
should be saved, before the device will go back to the settings menu.
Default settings
The device settings buzzer, timer step-size, and mask pre-set will be
set to factory default. Also, the user specied pre-sets will be cleared
to factory default.
Adjust menu
Pre-sets P13, P14, and P15 can be adapted for user specied pre-
sets. With these pre-sets, it is possible to combine the basic pre-sets
P1 – P9 or to customize the parameters of the basic pre-sets. In
default, these pre-sets are not activated. To activate these pre-sets go
the “mask pre-set” menu, so these pre-sets can be unmasked.
Configure a user specified pre-set only in consultation with the
treating specialist.

18 i-Pulz 2
To create a user specied pre-set, turn ON the
device and select P13, P14, or P15 to congure.
Press the Power button and the pre-set button
together to switch to the Adjust menu. (make
sure the intensity is 0.0 mA)
To switch back to the normal menu, press shortly
on the Power button again. The device will ask to
save the adjustments.
In the adjust menu, it is possible to select one
of the basic pre-sets for the right channel and
another basic pre-sets for the left channel.
Pre-set P10 can’t be combined with other pre-
sets.
With the Left Up/Down button, you can select P1 till P10 for the Left
channel. And the Right Up/Down button for the Right channel. See
Figure 3 adjust menu”.
To customize the parameters of these basic pre-
sets, press on the pre-set button. First, you can
adjust the parameters of the Left channel.
Depending on which basic program is selected,
various parameters can be changed. See the
section Pre-set overview.
• Use the Timer button to step through these various parameters.
• Use the Left Up/Down buttons to adjust the value of the parameter.
When the parameters for the Left channel are
set, press the pre-set button to switch to the
parameters for the Right channel.
• Use the Timer button to step through the
various parameters.
• Use the Right Up/Down button to adjust the
value of the parameter.
By pressing the pre-set button again, the adjust menu will start over
again, and you can select the basic pre-sets again.
Figure 3 adjust menu

19i-Pulz 2
Low and rest intensity
When a basic pre-set P4 or P7 is selected as a user specied pre-set,
you can set the separate intensity for the low-frequency period or the
rest period. Therefore, set the “low/rest intensity parameter” ON in the
adjust parameter menu.
When this pre-set is started, rst the desired
main intensity for the main frequency will be
set. After that, it is possible to set the intensity
for the lower or rest-period. To do this, press
on the intensity value at the screen. Now the
display changes like you can see in gure 6,
and it is possible to set the intensity of the lower
frequency or rest-period. This can be set 50%
higher or lower than the main frequency intensity.
Press on the screen at the intensity value again
to switch back to the normal screen.
When adjusting the main intensity level halfway the treatment, the low
or rest intensity-level will be reset to the same intensity as the main
intensity level.
Compliance menu
In the compliance menu, it is possible to see the usage of the device.
The pre-set, intensity, and time of each use will be stored in the device.
This information can be used by a medical specialist, doctor, caregiver
or parent to verify correct use according to the instructions.
When the device is ON, press the Power button and the Timer button
simultaneously to switch to the compliance menu. The compliance
menu can be exited with a short press on the Power button. The
device asks to clear the compliance menu and switch back to the
normal menu.
When the compliance is opened, it displays the following information.
The Session Number + date indicates when the treatment happened.
Of every treatment, it shows; the used pre-set number, the intensity,
and the time per channel (in minutes).
The date is based on the time set in the device. If the device-time is
inaccurate, it can give a misrepresentation of the date. See settings
menu - time to set the correct time in the device.
Figure 6 set low / rest
intensity

20 i-Pulz 2
Controls
• With the Left Up/Down button, you can step through the sessions
one by one.
• With the Right Up/Down button, you can step 10 sessions further.
• With the Timer button, you can step to the last session.
• With the pre-set button, you can step to the rst session.
Charging
The i-Pulz 2 has a built-in Li-ion battery for long term use. This battery
is not user-replaceable and can only be changed by qualied service
personnel. The expected service life of the battery is ve years, based
on 1000 charge cycles. The battery life strongly depends on its use.
The battery must be charged at least once per six months, to prevent
loss of total maximum capacity of the battery.
The i-Pulz 2 makes use of wireless charging technology, which means
that no cable needs to be connected to the i-Pulz 2. To get the i-Pulz 2
charged, connect the power adapter to the wireless charge-pad. Plug
the power adapter into the mains power socket. Place the i-Pulz 2 on
the centre of the wireless charge-pad. The indicator LED on the i-Pulz
2 will light-up orange, the device is now charging.
The indicator LED on the wireless charge-pad will light-up blue when it
starts charging. When the battery is almost full, the LED on the i-Pulz 2
will light up green and the blue LED of the charge-pad will turn off.
The i-Pulz 2 can be picked up from the wireless charger at any time.
The indication LED in the i-Pulz 2 stays on for 10 seconds with the
status of the battery. Red is empty, orange mid full, green is full.
When the indicator LED is red, the battery is too low to switch the
device on.
To get the best charge performance, make sure that:
• The originally supplied charger is used.
• The i-Pulz 2 is placed at the centre of the charge-pad.
• Any obstructions from/between the i-Pulz 2 and the charging
surface are removed. Also, make sure the i-Pulz 2 is placed on the
charging surface properly.
• The charging-process is done indoor at a clear space to enable
ventilation.
• To save energy, unplug the charger when not in use.