I-Tech MIO-IONOTENS User Manual Download

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IACER Srl

MNPG151-08

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-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

Summary of Contents for MIO-IONOTENS

Page 1: ...USER MANUAL Electrotherapy MIO IONOTENS ...

Page 2: ......

Page 3: ... 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 EL...

Page 4: ...IV ...

Page 5: ...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 Le...

Page 6: ...ulatory 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 T...

Page 7: ...ower 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 Co...

Page 8: ...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...

Page 9: ...H2 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 ...

Page 10: ...ion 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 ...

Page 11: ...or 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 positio...

Page 12: ...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...

Page 13: ...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 equipme...

Page 14: ...arotid 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 thisstimulation couldcauseimportantmusclespasmsthatcan obstructthe 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 in...

Page 15: ... 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...

Page 16: ...low 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 displ...

Page 17: ...reating 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...

Page 18: ... 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 ...

Page 19: ...0 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 50µs Total time 10 min frequency 90 Hz impulse wi...

Page 20: ... 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 50µs Total time 10 min frequency 70 Hz impulse w...

Page 21: ...as pain Conventional TENS activates large diameter nerve fibres blocking the path of small diameter nerve fibres at the spine Therefore this action is mainly taken against the symptom to simplify it further the wire transmitting pain information is obstructed Conventional TENS is a current that can be used to treat general daily pain The average number required to benefit from the treatment is 10 ...

Page 22: ...e 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 That is the reason why such stimulation is undoubtedly the least tolerated but it is extremely effective This type of st...

Page 23: ...n sensitivity to reach a level of stimulation that is comfortable for you TENS6 Back Sciatic pain medical program Specific program for the treatment of pain in the lumbar area or along the sciatic nerve or both 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 t...

Page 24: ...s immediate Two treatments per day for three or four days are recommended Session duration 30 minutes Electrodes positioning photo from 01 to 28 in the Positions manual Intensity to be adjusted in order to have a moderate muscle solicitation TENS10 Hand and wrist pain medical program This program is suitable for all types of hand and wrist pain aching caused by strains arthritis in the hand carpal...

Page 25: ...rochlea Pain is felt when bending or straightening the wrist against resistance or when clenching a hard rubber ball in the hand It is recommended 15 applications once a day even twice until the symptoms pass First it is recommended that you consult your doctor to identify the precise cause of the pain in order to prevent the condition from reoccurring Session duration 40 minutes Electrodes positi...

Page 26: ...eadache TENS5 10 12 Daily even twice a day Photo 25 Back pain TENS6 10 12 Daily Photo 25 but with all electrodes placed 10 cm lower Backache TENS6 12 15 Daily Photo 27 Sciatic pain TENS6 15 20 Daily even twice a day Photo 28 Cruralgia TENS6 15 20 Daily even twice a day Photo 18 with all electrodes placed on the inside of the thigh Epicondylitis TENS12 15 20 Daily even twice a day Photo 29 Hip pain...

Page 27: ...s programs the stimulation intensity shall be adjusted to feel a remarkable tingling in the treated area producing a slight contraction of the surrounding muscles If you feel discomfort or pain reduce the intensity and eventually stop the therapy The ionophoresis treatment exploits the polarity negative or positive that characterizes a specific drug selected on the basis of the therapy to be condu...

Page 28: ...nalgesic Extra intra articular arthrosis rheumatism Local anesthetics novocaine lidocaine Negative Analgesic Local anesthesia trigeminal neuralgia Benzidamina Positive Analgesic Rheumatoid arthritis Diclofenac sodium Pos Neg Analgesic hematoma Orudis Voltaren Lometacen Arfen Tilcotil Axera Naprosyn Negative Anti inflammatory Degenerative and extra articular rheumatism gout Piroxicam Feldene Positi...

Page 29: ... drugs these can be dissolved on either the positive pole or the negative pole At this point insert the two black rubber electrodes previously connected to the electrostimulation cable inside the sponge coverings one with the drug and the other without Position the electrode with the drug on the painful area and the other electrode on the other side Figure 2 with the help of the elastic band suppl...

Page 30: ... Ionophoresis H high Total time 30 min Frequency 1200 Hz Width impulse 100µs 4 Yes Microcurrent Total time 30 min Frequency 90 Hz Width impulse 20µs 5 Yes Hematoma Total time 30 min 5 sec 30 Hz 200 µs 5 sec 50 Hz 150 us 5 sec 100 Hz 120 µs x 120 cycles 6 Yes Oedema Total time 30 min 6 sec 100Hz 175 µs 6 sec 2 100Hz modulated 250 µs 6 sec 150Hz 60 200 µs 7 Yes Tens sequential Total time 30 min 6 se...

Page 31: ...Hz 250µs 80 5 sec 30Hz 250µs 80 x 40 cycles 10 Yes Atrophy Total time 4min Frequency 6Hz Width impulse 250µs Total time 15 min 10 sec 3Hz 250µs 80 5 sec 40Hz 250µs 80 x 40 cycles Total time 10 min 10 sec 3Hz 250µs 80 5 sec 50Hz 250µs 80 x 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 progra...

Page 32: ...d has very few contraindications those specified in the paragraph Contraindications Session duration 30 minutes Position of electrodes above the painful area as shown in Figure1 Intensity set above the threshold of perception REHA5 Hematomas medical program Consult a doctor before using this program to treat haematomas Few applications carried out within a few hours of the bruise are recommended A...

Page 33: ... square above the area to be treated as shown in Figure 1 REHA9 Atrophy prevention medical program Program created to maintain muscle trophism This treatment concentrates on muscle toning paying particular attention to slow twitch fibres Particularly indicated for patients recovering from an accident or an operation Prevents the reduction of muscle trophism caused by physical inactivity The muscle...

Page 34: ...0 sec slope 0 5 sec recovery time 0 30 sec width impulse 50 450µs 11 12 No Free memories NEMS alternated CH1 CH2 Total time 1 90 min frequency 1 200 Hz contraction time 1 10 sec slope 0 5 sec recovery time 0 30 sec width impulse 50 450µs 13 No Battery test M1 M5 TENS Free memories medical program Free memories for antalgic TENS treatment M6 M10 NEMS Free memories non medical program Free memories ...

Page 35: ...the battery before proceeding with the cleanliness of the device Device not subject to sterilization Note Never use solvents for cleaning Cleaning agents cause damage to the device Attention to the need for periodic maintenance especially inspection of main body for cracks which may allow the ingress of conductive fluid inspection of the main cable and associated connectors TRANSPORTATION AND STOR...

Page 36: ...IO IONOTENS must be verified before sending the device to the manufacturer Here below are some typical situations MIO IONOTENS cannot be turned on and or the display does not light up Check the battery status and replace it if it is necessary refer to chapter Battery replacement If the problem persists contact the manufacturer MIO IONOTENS does not transmit electric impulses Check that the cable j...

Page 37: ...IO IONOTENS and connect the battery charger into the power socket The display will show the battery blinking icon and the TIME min icon which takes account of the charging time on the display After 4 hours the recharge automatically finishes and the display shows the recharge total time At the end of battery charging disconnect the charger from power supply and store it in the carriage bag WARNING...

Page 38: ...e the recharging Use only the original battery charger or in any case the battery charger supplied by the fabricant distributor 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 regardin...

Page 39: ...ollowing paragraph Warranty conditions The warranty is provided by IACER Should you need to return the goods then please pack the device and all the accessories so that it won t be damaged during transportation In order to be entitled to the warranty assistance the purchaser must enclose to the device a copy of the purchasing receipt proving origin and purchasing date For more information on the w...

Page 40: ...Technical documentation related to repairable parts could be attached but only with previous authorization from the manufacturer and only after giving proper training to the staff employed in technical assistance Spare part The manufacturer makes available at any time the original spare parts for the equipment Please contact I A C E R S r l Via Enzo Ferrari 2 30037 Scorzè VE Tel 041 5401356 Fax 04...

Page 41: ...rs away from televisions monitors cellphones or any other electronic equipment in particular portable RF communications equipment including peripherals such as antenna cables and external antennas should not be used closer than 30cm 12 inches to any part of the device including the cables specified by the manufacturer otherwise it could lead to degradation of the performance of the MIO IONOTENS In...

Page 42: ...ronment guidance RF emissions CISPR 11 Group 1 MIO IONOTENS uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B MIO IONOTENS is suitable for domestic establishment and in establishment directly connected to the public low voltage power supply network that supp...

Page 43: ...lines Mains power quality should be that of a typical commercial or hospital environment 1kV for input output lines 1kV for input output lines Impluses IEC 61000 4 5 0 5kV 1kV Line s to line s 0 5kV 1kV Line s to line s Mains power quality should be that of a typical commercial or hospital environment 0 5kV 1kV 2kV Line s to earth 0 5kV 1kV 2kV Line s to earth Voltage dips short interruptions and ...

Page 44: ...is used in such an environment Immunity test Test level IEC 60601 Compliance level Electromagnetic environment guide 0 UT for 250 300 cycles 0 UT for 250 300 cycles power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30A m 30A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note U...

Page 45: ...watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz At 80 MHz and 800 MHz...

Page 46: ...ansmitter m from 150kHz to 800 MHz from 80MHz to 800 MHz from 800MHz to 2 7GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rati...

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