I-Tech MIO-IONOTENS User Manual
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I-Tech MIO-IONOTENS User Manual

Electrotherapy
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USER MANUAL
Electrotherapy
MIO-IONOTENS

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Summary of Contents for I-Tech MIO-IONOTENS

  • Page 1 USER MANUAL Electrotherapy MIO-IONOTENS...
  • Page 3 INDEX INDEX TECHNICAL INFORMATION ANUFACTURER ECLARATION OF CONFORMITY LASSIFICATION URPOSE AND SCOPE ECHNICAL FEATURES 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 REHA programs MEM programs...

  • Page 5: Technical Information

    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...

  • Page 6: Purpose And Scope

    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...

  • Page 7: Technical Features

    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).
  • Page 8 Characteristic Specifications 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 From 700 to 1060hPa pressure WARNING: the device has an output current over 10mA.
  • Page 9 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.
  • Page 10 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 11: Packaging Content

    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;...
  • Page 12 (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...
  • Page 13 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 •...
  • Page 14 • 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;...

  • Page 15: Patient Preparation

    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);...

  • Page 16: Device Use

    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.
  • Page 17 TIME-min, ▲(increase) 2. Adjust therapy time pressing ▼(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.
  • Page 18 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 19 Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No impulse width 200µs Total time 3min frequency Tens at 150Hz maximum impulse values width 200µs Total time 30 min frequency Anti- inflammatory 120 Hz impulse width 40µs Total time Total time Total time 5 min 20 min...
  • Page 20 Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No frequency 2 Hz impulse width 200µs Total time Total time Total time 10 min 10min 10min frequency frequency frequency Muscle 4 Hz relaxant impulse impulse impulse width width width 250µs 200µs 300µs Total time...
  • Page 21 Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No Total time Total time Total time 1 min 30 min 10 min: frequency Frequency (3Hz-200µs 150 Hz 90Hz x 7sec impulse impulse 50%+ 1Hz- width Periarthritis width 60µs 200µs x 3 200µs sec 60% + 30Hz-...
  • Page 22 TENS2 • TENS endorfinico (medical program) Questo tipo di stimolazione produce due effetti in relazione al posizionamento degli elettrodi: posizionando gli elettrodi in zona dorsale con riferimento foto 08 del Manuale posizioni, favorisce la produzione endogena di sostanze morfinosimili che hanno la proprietà di innalzare la soglia di percezione del dolore.
  • Page 23 Intensity: to be adjusted until a tingling feeling is produced in the area treated; avoid contracting the surrounding muscles. TENS5 • Neck pain/Headache (medical program) Specific program for the treatment of pain in the neck area. The first benefits can be seen after 10 to 12 treatments carried out on a daily basis; proceed with the treatment until the symptoms pass.
  • Page 24 Intensity: to be adjusted between the threshold of perception and pain. TENS8 • Vascularization (medical program) This program has a vascularizing effect on the treated area. Vascularization increases arterial flow and consequently aids the removal of allogenic substances and helps to restore normal physiological conditions. Do not position the electrodes close to inflamed areas.
  • Page 25 Electrodes’ positioning: 2 electrodes on the sole of the foot (one positive, the other negative), one close to the toes and the other under the heel. Intensity: just a little bit over the perception threshold. TENS12 • Epicondylitis (medical program) Also known as “tennis elbow”, it is an insertional tendinopathy concerning insertion of the elbow bone into the epicondylar muscles, those enabling finger and wrist extension (bending backwards).
  • Page 26 Intensity: to be adjusted above the perception threshold with small muscle contractions at the end of the program (10 minutes before the end). Treatment programs for TENS therapy Electrodes’ No. of Frequency of Pathology Progr. positioning treatments treatments reference TENS1 Daily (TENS1 up to Until pain On the painful...
  • Page 27 Electrodes’ No. of Frequency of Pathology Progr. positioning treatments treatments reference TENS1 + Daily, even twice a Wryneck 8/10 Photo 25 TENS 9 Periarthritis TENS14 15/20 Daily Photo 26 The indications of the electrodes’ positioning are available in the Positions manual.
  • Page 28 Table of the main drugs used in the iontophoresis treatments Drug Polarity Prevalent action Indications syndrome. Do not use in case of arteriosclerosis Analgesic, Calcium chloride Magnesium chloride sedative, substitute in Positive (Sol. 10%) fibrolytic patients with arteriosclerosis Sclerolytic, Scars, Potassium iodide Negative emollient...
  • Page 29 Before starting the ionophoresis session, clean the skin near the area to be treated; connect the jacks of the electrostimulation cable to the black rubber electrodes with cable disconnected from MIO-IONOTENS. Moisten the two sponge electrodes abundantly. ATTENTION: wring the sponge electrodes to avoid dripping, then put the drug on an electrode as follows: •...
  • Page 30 Programs specifications Medical prg. Description PHASE 1 PHASE 2 PHASE 3 Yes/No Total time 30 min Frequency 800 Hz Ionophoresis Width impulse L (low) 100µs Total time 30 min Ionophoresis Frequency 1000 Hz Width impulse M (medium) 100µs Total time 30 min Frequency 1200 Hz Ionophoresis H (high)
  • Page 31 80%) 40 cycles 40 cycles Make sure that MIO-IONOTENS is switched off before disconnecting the electrodes at the end of the treatment. REHA1-2-3 • Ionophoresis L-M-H (medical program) At the end of the program, the skin could lightly turn bright red; the reddening usually vanishing few minutes after the end of program.
  • Page 32 Channel 2 is disconnected. Session duration: 30 minutes. Electrodes position: place the electrode with the drug on painful area and the other electrode on the opposite side. Intensity: must be strong enough to produce a relevant perception, near pain, till the muscles surrounding the area treated begin to contract. REHA4 •...
  • Page 33 Intensity: should be adjusted to a level between the thresholds of perception and pain without muscle contractions at least in the first two weeks then gradually increase. REHA7 • TENS sequential (medical program) During stimulation, this program modifies by itself the frequency and impulse width.
  • Page 34 Position of electrodes: from photo 1 to photo 20 of the Positions manual. Intensity: Apply with caution (at low intensity, enough to produce light muscle contractions) in the first 2/3 weeks. Increase intensity progressively over the next 3/4 weeks. MEM programs Medical prg.

  • Page 35: Maintenance

    Store the device in a cool, well-ventilated place. Do not store heavy objects on the device. It is recommended to switch off MIO-IONOTENS at the end of each treatment and to remove the cables from the connectors. MIO-IONOTENS should be kept...

  • Page 36: Troubleshooting

    It could severely damage the cables. Troubleshooting Any type of work on MIO-IONOTENS must be carried out exclusively by the manufacturer or by an authorized dealer. In any event, any presumed malfunction of MIO-IONOTENS must be verified before sending the device to the manufacturer.

  • Page 37: Battery Charging

    If the problem persists, contact the manufacturer. • MIO-IONOTENS 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...

  • Page 38: Battery Substitution

    Not open or modify the battery charger. Disposal MIO-IONOTENS was designed and engineered to have minimal negative environmental impact, in consideration of its performance and safety requirements, following the disposition given by the European Directive 2012/19/EU, regarding the waste of electrical and electronic equipment.

  • Page 39: Warranty

    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. Warranty IACER Srl guarantees a warranty period from the purchasing date for MIO- IONOTENS device, unless information contained in this manual regarding...

  • Page 40: Technical Standard

    Electromagnetic interferences electromagnetic compatibility tables The MIO-IONOTENS equipment has been designed and manufactured according TECHNICAL STANDARD ELECTROMAGNETIC COMPATIBILITY legislation EN 60601-1-2:2015 with the aim of providing adequate protection from harmful interference when installed in homes and health establishments.

  • Page 41: Electromagnetic Compatibility Tables

    MIO-IONOTENS. In conclusion, the use of MIO-IONOTENS adjacent to or stacked with other equipment should be avoided, since it could cause improper functioning. If such use is necessary, the MIO-IONOTENS and the other equipment should be constantly observed to verify that they are operating normally.
  • Page 42 Guidance and manufacturer’s declaration – ELECTROMAGNETIC EMISSIONS – FOR ALL EQUIPMENT AND SYSTEMS MIO-IONOTENS is intended for use in the electromagnetic environment specified below. The customer or the user of MIO-IONOTENS should assure that it is used in such an environment. Electromagnetic environment -...
  • Page 43 Guidance and manufacturer’s declaration – ELECTROMAGNETIC IMMUNITY – FOR ALL EQUIPMENT AND SYSTEMS MIO-IONOTENS 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 44 Guidance and manufacturer’s declaration – ELECTROMAGNETIC IMMUNITY – FOR ALL EQUIPMENT AND SYSTEMS MIO-IONOTENS 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 45 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which MIO- IONOTENS is used exceeds the applicable RF compliance level above, MIO-IONOTENS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating MIO- IONOTENS.
  • Page 46 MIO-IONOTENS that are not life-supporting MIO-IONOTENS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of MIO-IONOTENS can help prevent electromagnetic interference by maintaining a minimum distance...

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