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I-Tech MIO CARE PRO User Manual
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I-Tech MIO CARE PRO User Manual

Electrotherapy
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USER MANUAL
Electrotherapy
MIO CARE PRO

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Summary of Contents for I-Tech MIO CARE PRO

  • Page 1 USER MANUAL Electrotherapy MIO CARE PRO...
  • Page 3 INDEX INDEX TECHNICAL INFORMATION ANUFACTURER ECLARATION OF CONFORMITY LASSIFICATION URPOSE AND SCOPE ARATTERISTICHE TECNICHE EVICE AND COMMANDS DESCRIPTION ABELS Packaging content HOW TO USE NTRODUCTION TO THE TECHNOLOGY ONTRAINDICATIONS Side effects ARNING ATIENT PREPARATION EVICE USE Operating instructions TENS programs Treatment programs for TENS therapy BEAUTY programs Treatment programs for muscles firming up and lipolysis...

  • Page 4: Declaration Of Conformity

    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.
  • Page 5 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; •...

  • Page 6: Caratteristiche Tecniche

    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’...
  • Page 7 Characteristics Specifications Command ABS keyboard with 9 keys Environmental From +5° to +40°C temperature Conditions of use Relative humidity From 30% to 75% Atmospheric From 700 to 1060hPa pressure Environmental From -10° to +55°C temperature Storage and transportation Relative humidity From 10% to 90% conditions Atmospheric...
  • Page 8 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.
  • Page 9 Labels Symbol Description Manufacturer’s logo. Product CE certification released by Notified Body n°0068. Applied part type BF according to EN 60601-1, 3 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.
  • Page 10 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; −...
  • Page 11 How to use Introduction to the technology MIO-CARE PRO is a portable generator of TENS and NEMS currents, specially designed for daily use in the treatments of the most common forms of muscular pains. Thanks to its TENS protocols, MIO-CARE PRO is particularly indicated for pain therapy.
  • Page 12 • 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;...
  • Page 13 • 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.

  • Page 14: Patient Preparation

    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.
  • Page 15 Operating instructions It is recommended reading the entire user manual before using. To start the therapy, turn MIO-CARE PRO 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 (NEMS, TENS, BEAUTY, MEM).
  • Page 16 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.
  • Page 17 Electrodes’ positioning and intensity levels IMPORTANT Create a square area with the electrodes over the painful zone. Keep 4cm minimum distance between the electrodes. Figure 1 – Electrodes’ positioning. 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).
  • Page 18 Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No impulse width 200µs Total time 30 Anti- frequency 120 inflammatory impulse width 40µs Total time Total time Total time 20 5 min 10 min frequency frequency Neck frequency 90 Hz 2 Hz 90 Hz pain/headache...
  • Page 19 Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No Total time 15 Total time Total time 15 min 10 min frequency 70 Hz frequency frequency Hand and wrist impulse width 90 Hz 110 Hz pain impulse impulse 60µs width width 50µs 50µs Total time 15...
  • Page 20 The indications of the electrodes’ positioning are available in the Positions manual. TENS1 • Fast TENS (medical program) Program also called conventional TENS, used for analgesic purposes; its purpose is to induce the organism into blocking pain at the spine, in accordance with the “Gate Control Theory”...
  • Page 21 Intensità: regolata in modo da produrre una buona sollecitazione della parte stimolata, la sensazione deve essere simile ad un massaggio. TENS3 • TENS at maximum values (medical program) This program blocks pain impulses peripherally creating a proper anaesthetizing effect in the treated area. This type of stimulation is suitable for injuries or bruises when rapid action is required.
  • Page 22 WARNING: the device varies stimulation parameters during the program. The current may be felt different: this is perfectly normal and is envisaged by the software: raise or lower the intensity according to your own sensitivity to reach a level of stimulation that is comfortable for you.
  • Page 23 TENS9 • Muscle relaxant (medical program) Program used to speed up the recovery of muscle function after intense training or strain from work; the effect is immediate. Two treatments per day for three or four days are recommended. Session duration: 30 minutes. Electrodes’...
  • Page 24 TENS13 • Epitrochlea (medical program) Also known as “golfing elbow”, it affects golfers but also those who carry out repetitive tasks or tasks involving frequent intense strain (for example carrying a particularly heavy suitcase). It causes pain in the flexor and pronator tendons inserted in the epitrochlea.
  • Page 25 Electrodes’ No. of Frequency of Pathology Progr. positioning treatments treatments reference placed 10 cm lower Backache TENS 6 12/15 Daily Photo 27 Sciatic pain TENS 6 15/20 Daily, even twice a day Photo 28 Photo 18 with all electrodes Cruralgia TENS 6 15/20 Daily, even twice a day...
  • Page 26 BEAUTY programs Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No Total time Total time 15 10 min: Total time 4 min: (3Hz- (3Hz-200µs 200µs x 7sec x 7sec 80%+ Firming up – frequency 6 80%+ 1Hz 1Hz 200µs x upper limbs 200µs x 3 sec 3 sec 100%...
  • Page 27 Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No sec 75%) x 40 cycles Total time 5 Total time 10 min: (3Hz- Total time 4 min: (3Hz- 200µs x 200µs x 7sec 7sec 80%+ frequency 6 Definition – 80%+ 1Hz 1Hz 200µs x upper limbs 200µs x 3 sec...
  • Page 28 Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No impulse impulse 250µs x 6 sec width width ch1 80%+ 40Hz- 250µs 250µs 250µs x 6 sec (80%) ch2 80%) x 60 cycles Total time min: Total time 5 Total time (5Hz-300µs x 8 4 min sec ch1/ch2...
  • Page 29 Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No impulse 100µs x 5 sec 100µs width 100%) x 40 (95%) 100µs cycles Total time 30 min: (1′ 3Hz - 300µs 100% + 1′ Capillarization 5Hz - 250µs 100%+ 1′ 8Hz - 200µs 100%) x 10 cycles...
  • Page 30 5. during contraction generated by the unit, contract the muscle voluntarily. A cycle of 15/20 applications must be completed before the first results can be seen; it is recommended one application for each muscle every two days with a day of rest in between. It is possible to work on pairs of muscles, for example thighs and abdominal muscles, treating one set one day and the other the next day.
  • Page 31 Intensity: it depends on the sensibility of the patient, it is recommended starting at low intensity levels and then gradually increase the intensity, never reaching or exceeding the pain threshold. BEAUTY5 • Definition upper limbs and trunk (non-medical program) BEAUTY6 • Definition lower limbs (non-medical program) These programs are Indicated for defining muscles in the arms and bust (BEAUTY5), or the legs (BEAUTY6), working on explosive fibres.
  • Page 32 BEAUTY8 • Microlifting (non-medical program) The following program is used to tone facial muscles using a special impulse to improve both the appearance and the dynamism of facial muscles. Session duration: 14 minutes. Electrodes’ positioning: photos 24 of the Positions manual. N.B. A minimum distance of 3 cm must be kept between the electrode and the eyeball.
  • Page 33 BEAUTY13 • Tissue elasticity (non-medical program) It is a two-phase program, that stimulates the superficial muscle fibres. The frequencies used facilitate the removal of substances accumulated on the surface and improve the dynamic appearance of the skin. Session duration: 19 minutes. Electrodes’...
  • Page 34 Electrodes’ Weekly training program No. of Muscle positioning Day 1 Day 3 Day 5 Day 7 weeks reference Thighs - BEAUTY Photo BEAUTY firming up BEAUTY1 BEAUTY1 11/18 BEAUTY1 Glutei - BEAUTY BEAUTY firming up Photo 19 BEAUTY2 BEAUTY2 BEAUTY1 Arms BEAUTY BEAUTY...
  • Page 35 NEMS programs Medical Description PHASE 1 PHASE 2 PHASE 3 Yes/No Total time 10 (5Hz- Total time 3 Total time 3 250µs x 7sec 80%+ Frequency 6 Frequency 8 Warming up 250µs x 3 sec 100% + 30Hz- impulse impulse 250µs x 5 sec width 250µs width 250µs...
  • Page 36 Medical Description PHASE 1 PHASE 2 PHASE 3 Yes/No Frequency 6 80%+ 80%+ 300µs x 3 sec 300µs x 3 sec impulse 100% + 20Hz- 100% + 50Hz- width 300µs 300µs x 8 sec 300µs x 5 sec 80%) x 45 75%) cycles cycles)
  • Page 37 Medical Description PHASE 1 PHASE 2 PHASE 3 Yes/No 80%) x 40 80%) cycles cycles Total time 10 Total time 10 (3Hz- (3Hz- Total time 4 200µs 200µs x 12sec Explosive 12sec 90%+ 90%+ Frequency 6 strength – 1Hz 200µs x 3 200µs x 3 sec upper limbs sec 100% +...
  • Page 38 Medical Description PHASE 1 PHASE 2 PHASE 3 Yes/No Frequency 6 Frequency 10 250µs x 8sec CH1&CH2 impulse impulse width 80%+ 50Hz width 250µs 250µs (80%) 250µs x 6 sec 75% CH1 + 50Hz 250µs x 6 sec 75% CH2) cycles Total time 10 Total time 3...
  • Page 39 Medical Description PHASE 1 PHASE 2 PHASE 3 Yes/No Total time 10 min (3Hz- Total time 10 Total time 10 250µs x 7sec 80%+ 1Hz- Frequency 6 Frequency Muscle 250µs x 3sec relaxant impulse 100% + 20Hz impulse width width 250µs 250µs x 5 sec 250µs (90%)
  • Page 40 IMPORTANT! Stimulation intensity during the contraction: the muscle must contract well without causing pain. It is recommended to voluntarily contract the muscle during the contractions induced by the electronic stimulator to reduce the sense of discomfort and improve the proprioceptive response: in this way, after electrostimulation, the stimulated muscle will be capable of contracting all of the muscle fibers and the parameters of strength and resistance will improve.
  • Page 41 NEMS4 • Resistant strength upper limbs and trunks (non-medical program) NEMS5 • Resistant strength lower limbs (non-medical program) This program is designed to help increase resistance to physical stress, or rather withstand intense exertion for a longer amount of time in muscle regions subjected to stimulation.
  • Page 42 Session duration: 24 minutes. Electrodes’ positioning: photo from 01 to 23 (21 excluded) of the Positions manual. Intensity: gradually increased session after session without overexerting the muscles until reaching the maximum level of tolerance. NEMS10 • Explosive strength upper limbs and trunks (non-medical program) NEMS11 •...
  • Page 43 Session duration: 25 minutes. Electrodes’ positioning: photo from 01 to 20 of the Positions manual, according to the area to be treated. Intensity: medium-low, increasing during the last 5/10 minutes. NEMS14 • Agonist/Antagonist (non-medical program) The electronic stimulator produces contractions alternated between 2 channels: during the first 4 minutes of warm-up the 2 channels work simultaneously, during the central work phase (15 minutes) muscle contractions are alternated between Channel 1 (agonist muscles) and Channel...
  • Page 44 NEMS17 • Sequential phasic contractions upper limbs and trunks (non- medical program) NEMS18 • Sequential phasic contractions lower limbs (non-medical program) This program produces rhythmic contractions with a stimulation frequency typical of fast-twitch fibers. Thanks to this stimulation frequency, it is suitable for increasing sequentially muscle strength.
  • Page 45 NEMS 21 • EMS rehabilitation (non-medical program) Program that increases microcirculation inside and around treated muscle fibers by creating rhythmic contractions, thus promoting a draining and toning action. Session duration: short, 5 minutes. Electrodes’ positioning: photo from 01 to 23 (21 excluded) of the Positions manual.
  • Page 46 MEM programs Medical prg. Description PHASE 1 Yes/No Total time 1-90 min Free frequency 1-200 Hz memoriesTENS width impulse 20-250 µs Total time 1-90 min frequency 1-200 Hz Free memories contraction time 1-10 sec 6-10 NEMS slope 0-5 sec recovery time 0-30 sec width impulse 50-450µs Total time 1-90 min frequency 1-200 Hz...

  • Page 47: Maintenance

    Device care Maintenance If used following the instructions given in this user guide, the equipment does not require any particular kind of maintenance. It is recommended that the manufacturer carries out a functional test every 24 months. The manufacturer does not consider the MIO-CARE PRO device repairable by any personnel outside the company.

  • Page 48: Troubleshooting

    and carefully stored on a secure surface. The performances of the equipment are granted if it is stored according to the following conditions: Outside the carrying bag: Temperature from 5 to +40°C Relative humidity from 30 to 75% Pressure from 700 to 1060 hPa Inside the supplied carrying bag: Temperature from -10 to +55°C...
  • Page 49 MIO-CARE PRO PHYSIO does not allow the intensity adjustment or not • keep the adjusted value and reset: It is suggested to replace the battery and start a new treatment. − If the problem persists contact the manufacturer Battery charging MIO-CARE PRO is supplied by internal rechargeable Ni-MH 800mAh battery with new long-lasting technology.
  • Page 50 Do not open the battery charger: it does not contain repairable parts. Battery substitution Remove the clip belt, then open the battery compartement on the back side of the device. Disconnect the cable and take away the battery. Connect the cable of the new battery, close the battery compartment and insert the belt clip.

  • Page 51: Warranty

    The correct disposal of obsolete equipment, accessories and most of all of batteries contributes in preventing possible negative consequences on human and environmental health. The user must dispose of scrap equipment by taking it to a recognized center for recycling of electrical and electronic equipment. For further information on the obsolete equipment disposal please contact the dedicated disposal service or the shop in which the device was bought.

  • Page 52: Technical Standard

    from personnel not authorized, accidental causes or negligence form the purchaser. 6) Warranty is not applied in case of damages caused by unsuitable power supplies. 7) Warranty does not apply to wearing parts. 8) Warranty does not include transportation costs which have to be covered by the purchaser.
  • Page 53 COMPATIBILITY legislation EN 60601-1-2:2015 with the aim of providing adequate protection from harmful interference when installed in homes and health establishments. The equipment does not generate significant radio frequency energy and is adequately immune to radiated electromagnetic fields. Therefore, it does not detrimentally interfere with radio-electric communications, electro-medical equipment for monitoring, diagnosis, therapy and surgery, office electronic devices such as computers, printers, photocopiers, fax machines, etc.
  • Page 54 For more details, please see the EMC tables at the end of this manual. IACER Srl MNPG148-06...

  • Page 55: Electromagnetic Compatibility Tables

    FOR ALL EQUIPMENT AND SYSTEMS MIO CARE PRO is intended for use in the electromagnetic environment specified below. The customer or the user of MIO CARE PRO should assure that it is used in such an environment. Electromagnetic environment -...
  • Page 56 Guidance and manufacturer’s declaration – ELECTROMAGNETIC IMMUNITY – FOR ALL EQUIPMENT AND SYSTEMS MIO CARE PRO is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
  • Page 57 Guidance and manufacturer’s declaration – ELECTROMAGNETIC IMMUNITY – FOR ALL EQUIPMENT AND SYSTEMS MIO CARE PRO is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
  • Page 58 If the measured field strength in the location in which MIO CARE PRO is used exceeds the applicable RF compliance level above, MIO CARE PRO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating MIO CARE PRO.
  • Page 59 MIO CARE PRO that are not life-supporting MIO CARE PRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of MIO CARE PRO can help prevent electromagnetic interference by maintaining a minimum distance...