I-Tech MIO-IONOTENS User manual

USER MANUAL
Electrotherapy
MIO-IONOTENS

III
INDEX
INDEX III
TECHNICAL INFORMATION 5
MANUFACTURER 5
DECLARATION OF CONFORMITY 5
CLASSIFICATION 6
PURPOSE AND SCOPE 6
TECHNICAL FEATURES 7
DEVICE AND COMMANDS DESCRIPTION 8
LABELS 10
Packaging content 11
HOW TO USE 12
INTRODUCTION TO THE TECHNOLOGY 12
CONTRAINDICATIONS 12
Side effects 12
WARNING 13
PATIENT PREPARATION 15
DEVICE USE 16
Operating instructions 16
TENS programs 17
Treatment programs for TENS therapy 26
REHA programs 27
MEM programs 34
DEVICE CARE 35
MAINTENANCE 35
TROUBLESHOOTING 36
Battery charging 37
Battery substitution 38
DISPOSAL 38
WARRANTY 39
Support 40
Spare part 40
ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES 40

IV

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Technical information
Manufacturer
I.A.C.E.R. S.r.l.
Via Enzo Ferrari, 2 • 30037 Scorzè (VE)
Tel. [phone] • Fax [phone]
IACER S.r.l. is an Italian manufacturer of medical devices (certified CE n°
0068/QCO-DM/234-2020 from the Notified Body n°0068 MTIC InterCert S.r.l.).
Declaration of conformity
I.A.C.E.R. S.r.l
Via Enzo Ferrari, 2 – 30037 Scorzè (Ve), Italia
herewith declares under its own responsibility, that the product
MIO-IONOTENS
UMDNS Code: 13762
has been designed and manufactured according to the European Medical
Device Directive 93/4/EEC (transposed in Italy by the D.Lgs. 46/97), as modified
by the Directive 2007/47/EC (D.Lgs.37/2010) and further
modifications/integrations.
The product has been assigned to class IIa, according to Annex IX, rule 9 of the
Directive 93/42/EEC (and further modifications/integrations) and bears the
mark
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123, Italia
Certified number: 0068/QCO-DM/234-2020
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
___________________ _____________________
Place, date Legal Representative
MASSIMO MARCON
Scorzè, 31/01/2022

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Classification
The MIO-IONOTENS has the following classification:
•class IIa (Directive 93/42/CEE, Annex IX, rule 9 and further
amendments);
•class II with BF type applied part (classif. EN 60601-1);
•equipment protection level IP22 against liquid and dust penetration;
•equipment and accessories not subject to sterilization;
•equipment unsuitable for use in presence of a flammable anesthetic
mixture containing air, oxygen and nitrous oxide;
•equipment suitable for continuous operation;
•equipment unsuitable for outdoors use.
Purpose and scope
Clinical intended use: Therapeutic
Environmental intended use: Ambulatory and home
MIO-IONOTENS is indicated for the treatment and the functional rehabilitation
of the following pathologies and anatomical zones:
•wrist articulation;
•hand articulation;
•shoulder articulation;
•foot articulation;
•ankle articulation;
•knee articulation;
•skeletal motor apparatus;
•arthrosis;
•atrophies and muscular dystrophy;
•bruises;
•sprains;
•neuralgias;
•benign lesions and muscular tears;
•tendinitis.
The MIO-IONOTENS electronic stimulator is a medical device specifically
intended for domestic use. It is also intended to be used by therapist, by
personal trainer in a center or private clinic.
MIO-IONOTENS is used to apply electrical micro impulses which create energy.
This energy, modulated with different parameters specific for different
impulses, can give the patient many benefits from pain relief to muscles cool

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down, from muscles strengthening to muscle tropism recovery, from isotonic
exercises to hematomas’ treatment, to treatments based on iontophoresis.
The patient population intended for electrotherapy treatment using the MIO-
IONOTENS device includes patients of both sexes, men and women, of age
(unless otherwise indicated by medical doctors). For further details, please
refer to the Contraindications section.
The CE0068 mark is only for the medical programs (see the following
paragraphs related to the detailed description of the programs).
Technical features
Characteristic
Specifications
Power supply Rechargeable batteries AAA Ni-MH 4.8V
800mAh
Recharger
power supply line AC 100-240V, 50/60Hz
200mA;
Output DC 6.8V, 300mA max.*
Isolation (EN 60601-1)
II
Applied part (EN 60601-1)
BF
Protection level
IP22
Applied part to the patient
Electrodes
Dimensions
(length x height x depth)
260x176x60mm
Weight main body
205gr including batteries
Layout
ABS
Number output channel
2 independent
Functioning
Continuous
Intensity
adjustable
Max output current
50mA, 1KΩload each channel in REHA
programs
99mA, 1KΩload each channel in the
remaining programs
Impulse
Biphasic compensated square wave and
monophasic square wave
Frequency
From 0.25 to 200Hz
Impulses’s width
From 20 to 450µs
Therapy
Time depending on the program (1-90 min)
Display
Reflective and illuminated LCD display
Command
ABS keyboard with 9 keys

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Characteristic
Specifications
Conditions of use
Environmental
temperature
From +5° to +40°C
Relative humidity
From 30% to 75%
Atmospheric
pressure
From 700 to 1060hPa
Storage and transportation
conditions
Environmental
temperature
From -10° to +55°C
Relative humidity
From 10% to 90%
Atmospheric
pressure
From 700 to 1060hPa
WARNING: the device has an output current over 10mA.
* Use only the battery recharger given by the manufacturer. The use of other
recharger could seriously compromise the security and safety both patient and
of the device.
Expected useful life of the device is set in 3 years, meanwhile the expected
useful life of the electrodes is set in 10/15 uses.
Device and commands description
1. CH1 output
2. CH2 output
3. Battery charger connector
4. Display

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5. Increase intensity CH1
6. Decrease intensity CH1
7. Mode operation button
8. Increase intensity CH2
9. Decrease intensity CH2
10. Increase program
11. Decrease program
12. ON/OFF and OK button
13. Set programs and therapy pause button
14. Belt clip
15. Battery compartment
1. Mode operation (TENS, REHA, MEM)
2. Wave frequency
3. Wave impulse width
4. Program number
5. CH1 intensity
6. CH2 intensity
7. Battery status
8. Therapy time
9. Contraction time
10. Recovery time
11. Up/down slope

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Labels
Symbol
Description
Manufacturer’s logo.
Product CE certification released by N
otified Body
n°0068.
Applied part type BF according to EN 60601-1, 3rd
edition.
Manufacturer.
Manufacturing date (YYYY-MM).
Read instructions for use.
The product must be disposed as “electronic waste”, in
accordance to WEEE Directive on waste electrical and
electronic equipment.
IP22
Medical device protected against the penetration of
solids (with a diameter d≥12,5mm
) and against the
vertical drops when the device is kept at 15° from its
normal functioning position.

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Symbol
Description
Limits of relative humidity (relative humidity
of the
storage environment, on the package).
Temperature humidity (temperature
of the storage
environment, on the package).
Packaging content
The MIO-IONOTENS pack contains:
−n° 1 MIO-IONOTENS device;
−n° 2 connection cables, for the transmission of electric impulses;
−n° 4 splitting leads;
−n° 1 packages containing 4 pre-gelled self-adhesive 41x41mm
electrodes (or 48x48mm);
−n° 1 packages containing 4 pre-gelled self-adhesive 40x80mm
electrodes (or 50x90mm);
−n° 1 ionophoresis kit (elastic belt, 2 silicon electrodes, 2 sponges)
−n° 1 battery pack (inside the device);
−n° 1 battery charger;
−n° 1 user manual;
−n° 1 user manual of the electrodes’ positions;
−n° 1 bag for the transportation.
Additional iontophoresis kits are available as accessories on request.

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How to use
Introduction to the technology
MIO-IONOTENS, thanks to its protocol’s TENS, is particularly suitable for the
treatment of pain. TENS pulses can significantly reduce, and in some cases
eliminate, the sensation of pain caused by diseases and / or problems indicated
above.
MIO-IONOTENS has also specific ionophoresis protocols. Ionophoresis is an
electrotherapeutic technique that uses continuous current to introduce drugs
on pain or contracture area. The current promotes the migration of the drug
ions: the drug passes through the pain area releasing its specific
action. Ionophoresis has two great advantages: it avoids the administration of
drugs by mouth and its treats directly the pain areas.
Ionophoresis is also used for the treatment of diseases affecting urogenital
male apparatus, like IPP (Induratio Penis Plastic) or La Peyronie disease. Consult
a specialist before starting the therapy. Contact the manufacturer for other
information.
Contraindications
The device must not be used in presence of cancerous injuries in the area to be
treated. The stimulation should not be applied to infected, swollen or inflamed
areas and in case of rashes (phlebitis, thrombophlebitis, etc.), open wounds
and dermatitis.
It is forbidden to use MIO-IONOTENS if the patient has a pacemaker, is
cardiopathic, suffers from epilepsy, is a pregnant woman, is an anxious person,
has severe disease, tuberculosis, juvenile diabetes, viral diseases (in the acute
phase), mycoses of inguinal or abdominal hernias, carriers of magnetizable
prostheses, acute infections, epileptics (except for different medical
prescriptions). Do not use the device if the source of the pain is unknown or not
diagnosed. Use the device ONLY after having a diagnosis. In the event of injury,
muscle stress or any other health problem consult your doctor before using the
device and only use it under medical supervision.
Side effects
No significant side effects are known. In some cases of particularly sensitive
people, skin redness occurs at the electrodes after treatment: the redness
normally disappears few minutes after treatment. If the redness persists,
consult a doctor.

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In some rare cases evening stimulation causes some difficulties in falling
asleep. In this case, suspend the treatment and consult a doctor.
Warning
It is recommended:
•to control position and meaning of all the labels on the equipment;
•not to damage the connection cables to the electrodes and to avoid
winding the cables around the device;
•to avoid the use of the device by persons who did not read carefully this
manual. Keep the device away from children, it contains small pieces that
could be swallowed;
•avoid use in damp environments;
•not to wear metal objects during treatment;
•to use the electrodes on clean and dry skin. When using the electrodes,
follow the instructions given in the manual and on the package of the
electrodes. Use only single-patient electrodes, supplied exclusively by the
manufacturer, and take care to avoid the exchange of electrodes between
different users. MIO-IONOTENS has been tested and guaranteed for the
use only with the electrodes supplied by the manufacturer;
•to use ONLY accessories supplied by device manufacturer. Only use
battery chargers supplied by the manufacturer; the use of battery
chargers not supplied by the manufacturer will free the same from any
responsibility related to damage to the equipment or user and will expose
the user to risks such as short circuits and fire.
It is forbidden:
•to use the device in the presence of patient monitoring equipment, of
electrosurgical (possible bruises and burns) or shortwave or microwave
therapy equipment or other equipment that sends electrical impulses
into the body and in general in combination to other medical devices,
since it could cause problems to the stimulator;
•to use the device by persons known to be unsound-minded, or suffering
from sensibility disorders, permanently or temporarily disabled unless
assisted by qualified personnel (e.g. a doctor or therapist); by persons
younger than 15 years old or not adequately educated about the device
use by an adult person;
•to use the device close to flammable substances/gas/explosives, in
environments with high concentrations of oxygen, with aerosol-therapy
devices or in wet environments (use of the device is prohibited in
bathroom or shower areas or while showering/bathing);

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•to use the device in presence of signs of deterioration of the device itself,
cables and accessories (electrodes, battery charger, etc.): please contact
the dealer or the manufacturer following the instructions given in the
paragraph Support. Control carefully the integrity of the device before
each use;
•to use the device while driving or during the operation and control of
equipment/machinery;
•to position the electrodes in such a way that the current crosses the heart
area (e.g. a black electrode on the chest and a red electrode on the shoulder
blade); however, electrodes can be positioned along the muscular fascia of
the heart area, as used for pectoral strengthening. Danger of heart arrythmia;
•to position the electrodes close to the eyes; make sure that the current
delivered does not cross the eyeball (one electrode diametrically opposite
to the other in relation to the eye); keep a distance of at least 3 cm from
the eyeball;
•to position the electrodes on the carotid sinuses (carotid) or genitals, in
particular in patient with a well-known sensibility on reflection of the
carotid sinuses; to position the electrodes near genitals and in those
areas that have poor sensibility;
•to stimulate the thyroid or apply stimulation on the neck and mouth, as
this stimulation could cause important muscle spasms that can obstruct the
airways, creating difficulty in breathing and problems with the heart
rhythm and blood pressure;
•to use pointed or sharp objects on the device keyboard.
Warning:
•insufficiently sized electrode sections can cause skin reactions or burns;
•do not use damaged electrodes even if they well adhere to the skin;
•be sure that the electrodes well adhere to the skin. Repeated use of the
same electrodes can compromise the safety of the stimulation, in fact it
can cause skin redness that can last for many hours after stimulation;
•pay attention to use connection cables with children/young people:
strangulation danger;
•do not mix connection cables up with earphones or other devices and do
not connect the cable to other equipment;
•keep right distance between electrodes: the contact between electrodes
could cause wrong stimulations or irritations/burns;
•stimulation intensity and electrodes position should be suggested by the
prescriber doctor.
The manufacturer considers himself responsible for the performances,
reliability, safety and security of the device only if:

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•any addition, modification and/or repair are carried out by authorized
personnel;
•the environmental electrical installation to which MIO-IONOTENS is
connected is compliant to the national laws;
•the instructions for use contained in this manual are strictly followed.
Should any foreign materials penetrate the device contact the retailer or
manufacturer immediately. If dropped down, check that the housing is not
cracked or damaged in any way; if so, contact the retailer or manufacturer.
Should you notice any changes in the device’s performance during treatment,
interrupt the treatment immediately and consult the retailer or manufacturer.
If the stimulation is uncomfortable decrease intensity. If the problem
persists consult a doctor.
Some patients could suffer from skin irritation or oversensitivity due
to stimulation or gel. If the problem persists, suspend the stimulation
and consult a doctor.
Consult a doctor before using MIO-IONOTENS with metallic
osteosynthesis devices.
IF YOU HAVE ANY DOUBTS REGARDING THE DEVICE USE CONSULT YOUR
DOCTOR.
Patient preparation
Before using MIO-IONOTENS clean the skin of the area to be treated; with the
cable disconnected from MIO-IONOTENS, connect the electrostimulation cable
jacks to the self-adhesive electrodes; position the self-adhesive electrodes on
the skin (see photos of electrode positions in the Positions manual); connect
the impulse transmission cables to the relative jacks (Channel 1 and/or Channel
2), then turn MIO-IONOTENS on.
Splitting leads use: please use splitting leads if you want to double electrodes
number for each channel. Connect the splitting cable jacks to the self-adhesive
electrodes, with the cable disconnected from MIO-IONOTENS; position the
self-adhesive electrodes on the skin (see photos of electrode positions in the
Positions manual); connect the splitting leads cables to the impulse
transmission cables that are connected to the relative jacks (Channel 1 and/or
Channel 2), then turn MIO-IONOTENS on.
Make sure that MIO-IONOTENS is switched off before disconnecting
the electrodes at the end of the treatment.

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Device use
MIO-IONOTENS is a portable and battery-powered device that generates TENS
and ionophoresis currents. It is particularly indicated for daily treatments of
the most commons muscle diseases.
MIO-IONOTENS has 14 preadjusted TENS programs, 10 preadjusted programs
REHA (including 3 programs iontophoresis) and 12 free memories adjustable
by the user to create programs according to his needs. The program MEM 13
is a battery test.
Operating instructions
It is recommended reading the entire user manual before using.
To start the therapy, turn MIO-IONOTENS on using the button.
PREADJUSTED PROGRAMS
Read the follow instructions to use the preadjusted programs and start the
therapy:
1. Select the program group using the MODE/ESC button (TENS, REHA,
MEM).
2. Select the program using PRG+ and PRG-buttons (refer to the follow
sections to get all technical specifications).
3. Increase current intensity for the channels using CH1 and CH2 (▲)
buttons. The value can be adjusted with stepping 1mA. Press CH1 and
CH2 (▼) buttons to decrease the intensity.MIO-IONOTENS recognize
the electrodes connection: in case of faulty connection, when the
intensity reaches 15mA the value is resetted to zero.
4. The remaining time is showed on the display of MIO-IONOTENS. An
acoustic signal advises the user when the treatment is completed.
5. Turn off the device keeping pressed the button for at least two
seconds.
FREE MEMORIES (ADJUSTABLE PROGRAMS)
With MIO-IONOTENS you can set the parameters according to your needs or
indicated by the doctor/physical therapist using the MEM programs.
Read the following instructions to adjust the parameters:
1. Select MEM by pressing MODE/ESC button. Scroll the programs using
PRG+ and PRG- buttons to display the preadjusted technical
specifications. Read the following instructions to adjust the chosen
program parameters: time, frequency and width impulse.

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2. Adjust therapy time TIME-min, pressing ▲(increase) and
▼(decrease) CH1 or CH2 buttons by increasing and decreasing the
time value. Press SET to confirm.
3. Adjust frequency HZ, pressing ▲(increase) and ▼(decrease) CH1 or
CH2 buttons by increasing and decreasing the frequency value. Press
SET to confirm.
4. Adjust width impulse µs, pressing ▲(increase) and ▼(decrease) CH1
or CH2 buttons by increasing and decreasing the width impulse value.
5. Press OK to confirm.
6. Increase intensity current of two channels using CH1 and CH2 (▲)
buttons. The value can be adjusted with 1mA stepping. Decrease the
intensity pressing CH1 e CH2 (▼) buttons.
Stop program command: press the button to pause the treatment. To
restart the program, press button.
Warning: the device automatically switches off when no button is pressed for
2 minutes to preserve battery by emitting an acoustic signal.
TENS programs
TENS, an acronym standing for Transcutaneous Electrical Nerve Stimulation, is
a therapeutic technique mainly used for analgesic purposes to counter the
effects (usually pain) of a wide variety of medical conditions. For this purpose,
it finds application in treating everyday ailments troubling mankind: neck pain,
arthrosis, myalgia, neuritis, back pain, periarthritis, heaviness in legs, muscle
weakness, just to mention a few.
On an academic level, TENS can be divided into various categories according to
the mechanism used to reduce the pain. The main types are: conventional TENS
(or fast analgesic), training TENS (or delayed analgesic), which is similar to the
effect of the electro acupuncture, TENS at maximum values with antidromic
action and consequently an immediate local anaesthetic effect.
The rehabilitative action of TENS is represented by its power to reduce pain
thereby restoring physiological conditions; most of the time this allows the
patient to regain normal motor function. Consider a patient suffering from
irritating periarthritis; the patient usually resorts to use analgesics or learns to
live with the pain, which often makes even the simplest movements
impossible. Immobility reduces metabolic activity making it impossible to
eliminate allogenic substances. So, a vicious circle begins. In addition to
relieving pain, TENS causes induce muscle stimulation increasing metabolic
activity and blood flow and improving tissue oxygenation with an intake of
nutritional substances. Therefore, the positive effect can be amplified by
combining TENS with muscle stimulation of the area concerned.

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Electrodes’ positioning and intensity levels
The electrodes have to be positioned to form a square over the painful zone by
using the channel 1 and 2 as shown above in Figure 1 (red or black up or down
are not important for the therapy purposes, follow the indications in the
Positions manual). The intensity should be adjusted to a level between the
thresholds of perception and pain: the maximum intensity level is the moment
in which the muscles surrounding the treated area begin to contract; over this
limit the stimulation does not become more effective, just more irritating, so it
is best to stop before that point.
Programs specifications
Prg
Medical
prg.
Yes/No
Description PHASE 1 PHASE 2 PHASE 3
1 Yes Conventional
Tens (fast)
Total time
40min
frequency
90Hz
impulse
width 50µs
2 Yes Endorphinic
Tens (delayed)
Total time
30min
frequency
1Hz
IMPORTANT
Create a square area with the
electrodes over the painful zone.
Keep 4cm minimum distance
between the electrodes.
Figure 1 – Electrodes’ positioning.

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Prg
Medical
prg.
Yes/No
Description PHASE 1 PHASE 2 PHASE 3
impulse
width
200
µ
s
3 Yes
Tens at
maximum
values
Total time
3min
frequency
150Hz
impulse
width
200µs
4 Yes Anti-
inflammatory
Total time
30 min
frequency
120 Hz
impulse
width 40
µ
s
5 Yes Neck pain/
headache
Total time
20 min
frequency
90 Hz
impulse
width 60µs
Total time
5 min
frequency
2 Hz
impulse
width
150µs
Total time
10 min
frequency
90 Hz
impulse
width 60µs
6 Yes Backache/
sciatic pain
Total time
20 min
frequency
90 Hz
impulse
width 50µs
Total time
20 min
frequency
60 Hz
impulse
width 60µs
7 Yes Sprains/
bruises
Total time
10 min
frequency
110 Hz
impulse
width 50
µ
s
Total time
10 min
frequency
90 Hz
impulse
width 50
µ
s
Total time
10 min
frequency
70 Hz
impulse
width 60
µ
s
8 Yes Vascularization
Total time
20 min

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Prg
Medical
prg.
Yes/No
Description PHASE 1 PHASE 2 PHASE 3
frequency
2 Hz
impulse
width
200µs
9 Yes Muscle
relaxant
Total time
10 min
frequency
4 Hz
impulse
width
250
µ
s
Total time
10min
frequency
6Hz
impulse
width
200
µ
s
Total time
10min
frequency
2Hz
impulse
width
300
µ
s
10 Yes Hand and wrist
pain
Total time
15 min
frequency
70 Hz
impulse
width 60µs
Total time
15 min
frequency
90 Hz
impulse
width 50µs
Total time
10 min
frequency
110 Hz
impulse
width 50µs
11 Yes Plantar
stimulation
Total time
15 min
frequency
70 Hz
impulse
width 60µs
Total time
15 min
frequency
2 Hz
impulse
width
150µs
Total time
10 min
frequency
90 Hz
impulse
width 50µs
12 Yes Epicondylitis
Total time
20 min
frequency
90 Hz
impulse
width 50
µ
s
Total time
10 min
frequency
70 Hz
impulse
width 60
µ
s
Total time
10 min
frequency
50 Hz
impulse
width 90
µ
s
13 Yes Epitroclea
Total time
20 min
frequency
90 Hz
impulse
width 50µs
Total time
20 min
frequency
70 Hz
impulse
width 60µs