I-Tech MIO CARE PRO Bedienungsanleitung

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

IACER Srl 4MNPG148-06

Technical information

Manufacturer

I.A.C.E.R. S.r.l.

Via Enzo Ferrari, 2 • 30037 Scorzè (VE)

Tel. 041.5401356 • Fax 041.5402684

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

IACER Srl 5MNPG148-06

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.

IACER Srl 6MNPG148-06

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)

Applied part (EN 60601-1)

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

IACER Srl 7MNPG148-06

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

IACER Srl 8MNPG148-06

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

IACER Srl 9MNPG148-06

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.

IACER Srl 10 MNPG148-06

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.

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