Terapio+ KTR-2493 User manual

SmartTENS
Wireless
Wireless
Pain Reliever
USER MANUAL
Transcutaneous Electrical Nerve Smulator
KTR-2493

Terapio.com
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DE
FR
ES
IT

1
ENGLISH
Read these instrucons for use carefully and
keep them for later use; be sure to make
them accessible to other users and observe
the informaon they contain.
TABLE OF CONTENT
Content of packaging ................................................................. 2
Geng to know your device ................................................... 2
Important notes .......................................................................... 3
Components of the device ...................................................... 7
Step-by-step operang instrucons ........................................ 8
Overview of the placement of the electrodes/pads ............. 9
Switching the device on and o ......................................... 10
Selecon of the funcon ....................................................... 11
Seng the treatment intensity levels ............................ 11
Adjustment of treatment duraon ..................................... 11
Troubleshoong ...................................................................... 12
Cleaning, storage and replacement parts .......................... 13
Warranty ...................................................................................... 14
The Paraphrase of Graphic Symbol ....................................... 14
Execuve Standards ................................................................ 15
Appendix EMC Declaraon ................................................ 16

2
Content of packaging
1. Wireless TENS Pain Reliever
2. 2x buery electropads
3. 1x remote control
4. 1x charging cable
Geng to know your device
What is a Wireless TENS Reliever unit and what
can it do?
The wireless TENS Pain Reliever is a medical device that
falls into the electrosmulaon device category. It oers a
wide range of funcons for increasing general well-being,
pain relief, maintaining physical tness, relaxaon, muscle
revitalisaon and combang redness.
TENS, or transcutaneous electrical nerve smulaon,
relates to the electrical smulaon of the nerves via the
skin. TENS is an eecve non-pharmacological method of
treang various types of pain that have a variety of causes.
It has no side-eects if administered correctly. The method
has been clinically tested and approved and can be used for
simple self-treatment.
The pain-relieving or pain-suppressing eect is achieved by
inhibing the transference of pain to nerve bres (caused
mainly by high-frequency impulses) and by increasing the
secreon of endorphins in the body. Their eect on the
central nervous system reduces the sensaon of pain.
The method is sciencally substanated and approved
as a form of medical treatment. Any symptoms that could
be relieved using TENS must be checked by your GP. Your
doctor will also give you instrucons on how to carry out a
TENS self-treatment regime.

3
TENS is clinically tested and approved to treat the
following:
• Back pain, parcularly in the lumbar/cervical spine area
• Sore joints (e.g. knee, hip and shoulder joints)
• Neuralgia
• Menstrual cramps in women
• Pain resulng from injury to the musculoskeletal system
• Pain caused by circulatory disorders
• Chronic pain with various causes.
Important notes
The device is not a substute for medical consultaon and
treatment. Consult your doctor rst if you are experiencing
any pain or are suering from an illness.
WARNING!
To avoid damage to health, we strongly advise against using
this unit in the following situaons:
• With implanted electrical devices (such as a pacemaker)
• In the case of metal implants
• If you use an insulin pump
• If you have a high temperature (e.g. > 39°C)
• If you have a known or acute cardiac arrhythmia, or
disorders of the heart’s impulse and conducon system
• If you suer from a seizure disorder (e.g. epilepsy)
• If you are pregnant
• If you have cancer
• Aer an operaon, if strong muscle contracons could
aect the healing process
• The device must never be used near to the heart. The
smulaon electrodes must not be placed on any part
of the front ribcage (where the ribs and breastbone
are located), especially not on the two large pectorals.
This can increase the risk of ventricular brillaon and
induce cardiac arrest.
• On the skeletal skull structure, or around the mouth,
throat or larynx
• In the neck/carod artery area
• In the genital area

4
• On acutely or chronically diseased (injured or irritated)
skin (e.g. inamed skin—whether painful or not—
reddened skin, rashes (e.g. allergies), burns, bruises,
swellings, both open and healing wounds, and post-
operave scars where the healing process could be
aected)
• In humid environments (e.g. in the bathroom)/when
bathing or showering
• Do not use aer consuming alcohol
• If connected to a high-frequency surgical device
• In the case of acute or chronic diseases of the
gastrointesnal tract
• The smulaon should not be applied above or through
the head, directly onto the eyes, covering the mouth,
to the front of the neck (especially not to the carod
artery), or with the electrode surfaces placed on the
chest and upper back or across the heart.
Before using the device, consult your doctor if any
of the following applies to you:
• Serious illnesses, in parcular if you suspect or have
been diagnosed with high blood pressure, a blood
coagulaon disorder, propensity to thromboembolic
condions or recurrent malignant growths
• Any skin condions
• Unexplained chronic pain in any part of the body
• Diabetes
• Any sensory impairment that reduces the feeling of pain
(e.g. metabolic disorders)
• If you are receiving medical treatment
• In the event of complaints linked to smulaon
treatment
• If you suer from persistently irritated skin due to long-
term smulaon at the same electrode site
Only use this unit
• On adults
• For the intended purpose and as specied in these
instrucons for use. Improper use can be dangerous.
• For external use
• With the original accessories supplied, which can be re-
ordered. Failure to do so invalidates the warranty

5
PRECAUTIONS:
• Always pull rmly on electrodes to remove them from
the skin to prevent injuries in the unusual case of highly
sensive skin.
• Keep the device away from sources of heat and do not
use it in close proximity (approx. 1 m) to shortwave or
microwave devices (e.g. mobile phones); doing so can
result in unpleasant current peaks.
• Do not expose the device to direct sunlight or high
temperatures.
• Protect the device from dust, dirt and humidity.
• Never immerse the device in water or other liquids.
• The device is suitable for self-treatment.
• For hygiene reasons, the electrodes may only be used on
one person.
• If the device does not work properly, or you feel unwell
or experience pain, stop using it immediately.
• Switch o the unit or the respecve channel rst before
removing or relocang electrodes in order to prevent
unintenonal smulaon.
• Do not modify electrodes (e.g. by cung them).
• Do not use the device whilst asleep, driving a vehicle or
operang machinery.
• Do not use whilst undertaking any acvity where an
unexpected reacon (e.g. strong muscle contracons
even at low intensity) could be dangerous.
• Ensure that no metallic objects (e.g. belt buckles or
necklaces) come into contact with the electrodes during
smulaon. If you are wearing jewellery or have piercings
in the area to be treated (e.g. a navel piercing), these
must be removed before using the device. Failure to do
so could result in spot burns.
• Keep the device away from children.
• Do not entangle the electrode cables (including contacts)
with headphones or other devices; do not connect the
electrodes to other devices.
• Do not use the device whilst using other devices that
transmit electrical impulses into your body.
• Do not use in the vicinity of highly ammable substances,
gases or explosives.
• Do not use rechargeable baeries; always use the same
baery types.

6
• During the inial few minutes, use the device while
sing or lying down to minimise the risk of injuries as a
consequence of isolated cases of vagal responses (feeling
of faintness). If you feel faint, immediately switch o
the device, lie down and support the legs in an elevated
posion (approx. 5-10 min).
• Treatment of the skin with moisturising loons or
ointments beforehand is not recommended as this
considerably increases the electrode wear and may cause
unpleasant current peaks.
• This device is not intended for use by people with
restricted physical, sensory (e.g. reduced sensivity to
pain) or mental skills or a lack of experience and/or lack
of knowledge, unless they are supervised by a person
who is responsible for their safety or are instructed by
such a person in how to use the device.
• If the adhesive capability of the adhesive electrodes
decreases, replace them immediately. Only use the
device again with new adhesive electrodes. Otherwise
the unequal adhesion of the adhesive electrodes may
lead to skin injuries. Replace the electrodes with new
ones aer having used them 20 mes at most.
Damage
• If the device is damaged, do not use I; contact your
retailer or the specied Customer Services address.
• In order to preserve the device’s eecveness, do not
drop it or disassemble it.
• Check the device for signs of wear and tear or damage.
If there are such signs or if the device has been used
improperly, it must be returned to the manufacturer or
retailer before further use.
• Switch the device o immediately if it is faulty or not
working properly.
• Do not aempt to open and/or repair the device
yourself. Repairs may only be carried out by Customer
Services or authorised retailers. Failure to comply will
result in voiding of the warranty.
• The manufacturer is not liable for damage resulng from
improper or careless use.

7

• The device is powered by a lithium baery, which can
be recharged via a USB cable
• If your skin or eyes come into contact with baery uid,
rinse the aected areas with water and seek medical
assistance.
• Choking hazard! Small children may swallow and choke
on baeries. Store the baeries out of the reach of
small children.
• If a baery has leaked, put on protecve gloves and
clean the baery compartment with a dry cloth.
• Protect baeries from excessive heat.
• Risk of explosion! Never throw baeries into a re.
• The rst note states the baery can be recharged or
short-circuit baeries.
• If the device is not to be used for a relavely
long period, take the baeries out of the baery
compartment.
Components of the device
F
88
88
8
A
M
min
Function/Mode
Intensity
Increase
Intensity button
Decrease
Intensity button
Countdown
Timer
Function/Mode
button
Power button
Power button
USB
Charging port

8
F
88
88
8
A
M
min
Function/Mode
Intensity
Increase
Intensity button
Decrease
Intensity button
Countdown
Timer
Function/Mode
button
Power button
Power button
USB
Charging port
Operang instrucons
step-by-step
Charging of the unit
1. Locate the micro USB charging port located at the
boom of the unit.
2. Plug in the supplied charging cable into the unit and
into any USB port.
3. Charge the unit for approximately two hours before
using it.

The power unit aaches to the main unit via two metal
press studs. Align the press studs, then push rmly unl the
control unit clicks into place.

9
Overview of the placement
of the electrodes/pads
Proper preparaon of the skin that is covered by the
electrodes allows a beer smulaon of the target ssue,
prolongs the life of the electrodes and reduces the risk of
skin irritaon.
Prepare your skin at the spots where the electrode will be
placed as follows:
1. Determine the spots where the electrode is to be placed.
2. Wash this area with mild soap and water (do not use
alcohol). Rinse and dry carefully.
3. Trim excess body hair in this area with a pair of scissors
(do not shave).
4. Treatment of the skin with moisturising loons or
ointments beforehand is not recommended as this
considerably increases the electrode wear and may
cause unpleasant current peaks, to supply the skin
with a protecve layer. Apply, let dry and aach the
electrode as described in this manual. In this way you
decrease the risk of skin irritaon and prolong the life of
your electrodes.
5. When you remove the electrodes, always pull them in
the direcon of the hair growth.
6. It may be helpful to apply skin loon to the area of the
electrode placement when you are not wearing the
electrodes.
LOWER BACK
Place the unit
vercally on each
side of your back
in the lower back
area.
UPPER BACK
Place the unit
vercally on each
side of your back
in the upper back
area.
SHOULDER
Place the unit on
the top part of
your shoulder.

10
STOMACH
MUSCLES
Place the unit
vercally on your
belly buon.
FRONT OF THE
THIGHS
Place the unit
vercally on the
front of the thigh
muscle.
BACK OF THE
THIGHS
Place the unit
vercally on the
back of the thigh
muscle. Do not
place pads too
low on the leg,
as this can lead
to unpleasant
contracons.
CALF MUSCLES
Place the unit vercally on each
calf muscle. Do not place the
pads too low on the leg, as this
lead to unpleasant contracons.
BUTTOCK
Place the unit
vercally on the
buocks, halfway
between the
centre line and the
side of your body.
Switching the device on and o
1. Press and hold the power buon on the unit to switch
on the device.
2. A beep will sound and a green light will show.
3. Now press the power buon on the remote control. Two
beeps will sound to indicate that the remote and the
device are paired.
4. The device turns o automacally aer treatment me
has elapsed.
5. Press the power buon to switch o the device
manually.
NOTE: Do not switch the device on unl the electrodes
have been connected correctly.

11
Selecon of the funcon
The device oers 15 therapeuc programs divided into
two funcons:
• Automac
• Manual
Upon acvaon the device is automacally set to auto-
mac. The leer “A” displays in the upper le corner of
the screen.
There are six modes in the automac funcon. Press the
“F” (funcon/mode) buon on the remote control quickly
to cycle through combinaons of pulses and nd a mode
that you prefer. Each me you switch Funcon or Mode
the device intensity will reset to level “1”.
To switch to manual, press and hold down the “F” buon
on the remote control. The leer “M” will display in the
upper le corner of the screen. Press the “F” buon briey
to cycle through the pulse modes. There are nine pulse
modes in Manual funcon.
To return to the automac funcon, press and hold down
the “F” buon once again.
Seng the treatment
intensity levels
There are 16 steps of intensity. Press the “+” buon on the
remote control repeatedly to increase the intensity to a
level you nd comfortable.
If the intensity becomes too strong, press the “–” buon
to reduce the strength of the pulses. The device will beep
with each step up or down in intensity.
Adjustment of treatment
duraon
Each session lasts for 15 minutes. The remaining minutes
of the session are displayed in the upper right corner of the

12
screen on the remote control.
The remote control will automacally turn o aer the 15
minutes have elapsed.
To begin another session, simply re-acvate the remote
control, or press the “+” intensity buon on the device.
The maximum recommended number of consecuve
sessions is four (60 minutes).
Troubleshoong
Before use you should check the device and accessories to
avoid damage or malfuncon. Some simple checks are:
1. Make sure that the unit is suciently charged and that
the remote control’s baery is full.
2. Ensure that the electropads are rmly inserted into the
socket device.
The table below shows some problems that may occur
occasionally. If you are unable to solve the problem
yourself please contact your authorised dealer or customer
service.
Problem Cause 
The device
does not turn
on
The baeries are
not charged or
running low
Recharge the
unit
The device
does not
turn on, but
generates
electrical
impulses
The baeries are
at, The elect-
ropad is defecve
or not properly
connected.
The duraon of
the treatment has
elapsed
Recharge the
unit; reconnect
the electropad
or use a new
one
Switch o the
device and
then switch it
back on again
The device
does not turn
on despite the
unit being fully
charged
Contact
customer
service

13
Cleaning, storage and
replacement parts
Adhesive electrodes
• To ensure that the electrodes remain adhesive for as
long as possible, clean them carefully with a damp,
lint-free cloth or clean the underside of the electrodes
under lukewarm, running water and pat dry with a
lint-free cloth. Reapply the electrodes to the carrier foil
following treatment.
Cleaning the device
• Remove the baeries from the device before cleaning.
• Clean the device aer use with a so, slightly damp
cloth. If it is very dirty, you can also moisten the cloth
with a mild soapy soluon.
• Do not use any chemical or abrasive cleaning agents.
Ensure that no water enters the device.
Reuse of the device
Once it has been properly prepared, the device can be used
again. Preparaon includes replacement of the treatment
electrodes as well as cleaning the surface of the device
using a cloth moistened with a mild soapy soluon.
Storage
• Do not bend the electrodes.
• Disconnect the electropads when not in use
• Reapply the electrodes to the carrier foil aer use.
• Store the device and accessories in a cool, well-
venlated space.
• Never place any heavy objects on the device.
Replacement parts
Order original electrodes and replacement parts from
terapio.com

14
Warranty
This product is guaranteed for a period of one year from
the date of purchase against mechanical and electrical
manufacturing defects. There are no serviceable parts
inside the device. Any aempted repair by unauthorised
persons invalidates the warranty. In the unlikely event that
you experience a problem, please return it to the retailer
where you made the purchase, along with your receipt. This
does not aect your statutory rights.
Contact customer support at terapio.com for any
assistance.
The Paraphrase
of Graphic Symbol
GRAPHIC
SYMBOL PARAPHRASE
Producon Batch
Product catalogue reference
code
Manufacturer
(Direcve 93/42/EEC amended
by Direcve 2007/47/EC)
DATE OF MANUFACTURE. This
symbol shall be accompanied
by a date to indicate the date of
manufacture.
Cauon
Applied part of type BF

15
European Authorized
Representave
Symbol for CE Mark. This symbol
ceres that a product has
met European Union consumer
safety, health, or environmental
requirements..
CE marking with the Registraon
Number of the Noed Body.
This denotes compliance with
European Direcve 93/42/EEC
concerning medical devices.
Level of protecon against the
inseron of solid bodies of size/
diameter ≥ 12 mm and liquids in
the presence of dripping water
when lted at 15° compared
with product.s.
Refer to instrucon manual/
booklet
Execuve Standards
The product conforms to the following standards and laws:
1. IEC 60601-1:2005+A1：2012 Medical electrical
equipment-Part 1: General requirements for basic safety
and essenal performance
2. IEC 60601-1-11：2015 Medical Electrical Equipment
- Part 1-11: General Requirements For Basic Safety
And Essenal Performance - Collateral Standard:
Requirements For Medical Electrical Equipment And
Medical Electrical Systems Used In The Home Healthcare
Environment
3. IEC 60601-2-10：2013 Medical electrical equipment -
Part 2-10: Parcular requirements for the safety of nerve
and muscle smulators
4. IEC 60601-1-2:2014 Medical Electrical Equipment - Part
1-2: General Requirements For Basic Safety And Essenal
Performance - Collateral Standard: Electromagnec
Disturbances - Requirements And Tests

16
Appendix EMC Declaraon
The equipment is intended for use in the electromagnec
environment specied below.
The customer or the user of the EQUIPMENT should assure
that it is used in such an environment.
The Transcutaneous Electrical Nerve Smulators is suitable
for use in a professional health care environment, not
including areas where there are sensive equipment or
sources of intense electromagnec disturbances, such as the
RF shielded room of an imaging system magnec resonance
imaging, in operang rooms near acve AF surgical
equipment, electrophysiology laboratories, armored rooms
or areas where short wave therapy equipment is used.
• Do not use the system around strong electric led,
lectromagnec led (e.g. MRI scan room) and mobile
wireless communicaon devices. Using the device in
an improper environment may cause malfuncon or
damage.
• The compliance with EMC and EMI regulaon cannot
be guaranteed by the use of modied cables or those
which does not comply with the same standards under
what the equipment was validated.
• The system must not be used adjacent or supported by
other equipment. The recommendaons of this manual
must be followed.
• Do not use accessories, transducers, internal parts
of components and other cables other than those
previously specied by the manufacturer. This
may result in increased emission or decreased
electromagnec immunity and result in improper
operaon.
• Portable RF communicaons equipment (including
peripherals such as antenna cables and external
antennas) should by used no closer than 30cm to any

17
part of the ultrasound system, including cables specied
by the manufacturer. Otherwise, degradaon of the
performance of this equipment could result.
• To maintain basic safety in relaon to electromagnec
disturbances during the expected service life, always
use the system in the specied electromagnec
environment and follow the maintenance
recommendaon described in this manual.

compliance of the equipment according to the
standard EN 60601-1- 2:2015.
Table 1 Compliance class

18
Table 2- Compliance standards