I-Tech MIO CARE PRO User manual

USER MANUAL
Electrotherapy
MIO CARE PRO

III
INDEX
INDEX III
TECHNICAL INFORMATION 4
MANUFACTURER 4
DECLARATION OF CONFORMITY 4
CLASSIFICATION 5
PURPOSE AND SCOPE 5
CARATTERISTICHE TECNICHE 6
DEVICE AND COMMANDS DESCRIPTION 7
LABELS 9
Packaging content 10
HOW TO USE 11
INTRODUCTION TO THE TECHNOLOGY 11
CONTRAINDICATIONS 11
Side effects 11
WARNING 11
PATIENT PREPARATION 14
DEVICE USE 14
Operating instructions 15
TENS programs 16
Treatment programs for TENS therapy 24
BEAUTY programs 26
Treatment programs for muscles firming up and lipolysis 33
NEMS programs 35
Treatment programs for muscle strength 45
MEM programs 46
DEVICE CARE 47
MAINTENANCE 47
TROUBLESHOOTING 48
Battery charging 49
Battery substitution 50
DISPOSAL 50
WARRANTY 51
Support 52
Spare part 52
ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES 52

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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-CARE PRO
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-CARE PRO 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-CARE PRO 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-CARE PRO electronic stimulator is a medical device specifically
intended for domestic use and is targeted to adults, who acquired the specific
knowledge to use the device by reading the present manual. It is also intended
to be used by therapist, by personal trainer in a center or private clinic and by
health professional in aesthetic center.

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MIO-CARE PRO 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
down, from muscles strengthening to drainage, from isotonic exercises to
hematomas’ treatment, to the treatment of the imperfections using the beauty
programs.
The patient population intended for electrotherapy treatment using the MIO-
CARE PRO 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).
Caratteristiche tecniche
Characteristics
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
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

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Characteristics
Specifications
Command
ABS keyboard with 9 keys
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 of the
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

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4. Display
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 (NEMS, TENS, BEAUTY, 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-CARE PRO pack contains:
−n° 1 MIO-CARE PRO device;
−n° 2 connection cables, for the transmission of electric impulses;
−n° 4 splitting leads;
−n° 1 packages containing 4 pre-gelled self-adhesive 41x41 mm
electrodes (or 48x48mm);
−n° 1 packages containing 4 pre-gelled self-adhesive 40x80 mm
electrodes (or 50x90mm);
−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.