MNPG151-00 (NUOVO MIO
Contents
1. cycles 250us 80 x 40 cycles R10 REHA 1 2 3 Ionophoresis 1 2 3 The intensity must be strong enough to produce a relevant perception near pain till the muscles surrounding the area treated begin to contract Electrodes position place the electrode with the drug on painful area and the other electrode on the opposite side REHA 4 Microcurrent The use of microcurrent is very similar to conventional Tens the only difference being the very fine electric impulse used that is sometimes more suitable for the sensibility of slightly anxious people or the more delicate parts of the body IACER S r l 18 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION It can generally be applied for everyday pains bearing in mind that you should always consult your doctor to identify the cause of the pain It is considered a good all purpose analgesic current as it does not have any side effects except slight skin redness after long applications and has very few contraindications those specified in the patagraph at the beginning Program duration 30 minutes Intensity set above the threshold of perception Position of electrodes above the painful area as shown in illustration 1 REHA 5 Hematomas Consult a doctor before using this program to treat hematomas Total program duration 30 minutes Few applications carried out within a few hours of the bruise A combination of various types of square w2. over this limit stimulation does not become more effective just more irritating so it is best to stop before that point The first benefits can be seen after 15 to 20 treatments carried out on a daily basis proceed with the treatment until the symptoms pass Program duration 40 minutes Position of electrodes see photo 27 and 28 in the manual of positions TENS 7 Sprains Bruises The program develops its effectiveness after this type of injury by inhibiting pain locally producing three selectively acting differentiated impulses The intensity should be adjusted to a level between the thresholds of perception and pain Number of treatments until pain is lessened on a daily basis even 2 3 times a day TENS 8 Vascularization Has a vascularizing effect on the area treated Vascularization increases arterial flow and consequently aids the removal of algogenic substances and helps to restore normal physiological conditions Do not position the electrodes close to inflamed ateas Daily application is recommended the number of applications is not defined the program can be used to reduce pain Stimulation intensity should be between the thresholds of perception and slight discomfort Program duration 20 minutes Position of electrodes see photo 25 and 33 in the manual of positions TENS 9 Muscle relaxant Program used to speed up the recovery of muscle function after intense training or strain from work the effect is
3. 2 5GHz eccetto quando rispettano le distanze di separazione raccomandate calcolate dall equazione applicabile alla frequenza del trasmettitore Distanze di separazione raccomandate d 1 2 P da 150kHz a 80MHz d 1 2 P da 80 MHz a 800 MHz d 2 3 P da 800 MHz a 2 5 GHz ove P la potenza massima nominale d uscita del trasmettitore in Watt W secondo il costruttore del trasmettitore e d la distanza di separazione raccomandata in metri m L intensit del campo dei trasmettitori a RF fissi come determinato in un indagine elettromagnetica del sito potrebbe essere minore del livello di conformit in ciascun intervallo di frequenza Si pu verificare interferenza in prossimit di apparecchi contrassegnati dal seguente simbolo Distanza di separazione raccomandata tra gli apparecchi di radiocomunicazione portatili e mobili e l apparecchio Il dispositivo previsto per funzionare in un ambiente elettromagnetico in cui sono sotto controllo i disturbi irradiati RF Il cliente o l operatore dell apparecchio possono contribuire a prevenire interferenze elettromagnetiche assicurando una distanza minima fra gli apparecchi di comunicazione mobili e portatili a RF trasmettitori e l apparecchio come sotto raccomandato in relazione alla potenza di uscita massima degli apparecchi di radiocomunicazione Potenza di uscita Distanza di separazione alla frequenza del trasmettitore m nomin
4. 25 January 2010 Notified Body Cermet Via di Cadriano 23 40057 Cadriano di Granarolo BO Italy MIO IONOTENS is a Class IIa equipment with reference to Directive 93 42 EEC MDD annexed IX rule 9 and following modifications Certification Path Annex II Mattellago 01 07 2014 Legal representative Mario Caprara Specifications MIO IONOTENS has the following specifications Class Ila equipment Directive 93 42 EEC annexed IX rule 9 and following modifications Class II applied part type BF Classif EN 60601 1 Equipment not protected against liquids penetration Equipment and accessories not subjected to sterilization Use of the equipment is prohibited close to flammable substances or in environments with high concentrations of oxygen Continuous operating mode equipment Equipment not suited to be used in external Purpose Clinical purpose Therapeutic Use Clinic Hospital and domestic use IACER S r l 4 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION 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 atticulation skeletal motor apparatus arthrosis atrophies and muscular dystrophy bruises sprains neuralgias benign lesions and muscular tears tendinitis MIO IO
5. Particularly indicated for patients recovering from an accident or an operation Prevents the reduction of muscle trophism caused by physical inactivity The muscle area concerned can be stimulated with daily applications of medium intensity if you increase the intensity leave a day of rest between applications to allow the muscles to recovet The intensity of this program must be adjusted to produce good muscle contraction in the atea treated Position of electrodes from photo 1 to photo 20 Program duration 24 minutes IACER S r l 19 of 24 MNP151 Rev 00 21 07 14 MEDICAL DIVISION REHA 10 Atrophy TE This program acts selectively on slow twitch fibres Ideal for recovering muscle trophism after a long period of inactivity or an accident Program to be carried out when loss of muscle tone has already occurred 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 Application on alternate days Position of electrodes from photo 1 to photo 20 Program duration 29 minutes MEM Programs Prg PHASE 1 TENS Free memories Total time 1 90 min frequency 1 200 Hz impulse width 20 520 us M1 M5 NEMS Free memories Total time 1 90 min frequency 1 200 Hz M6 M10 contraction time 1 10 sec slope 0 5 sec Recovery time 0 30 sec impulse width 50 450us NEMS Free memories alternate channel 1 and 2 Total time 1
6. The electrodes must not be positioned on the carotid sinuses carotid or genitals The electrodes must not be positioned close to the eyes make sure that the current delivered does not cross the eyeball one electrode diametrically opposite to the other in relation to the eye keep a distance of at least 3 cm from the eyeball Insufficiently sized electrode sections can cause skin reactions or burns Do not use electrodes when damaged even if they stick to the skin well Use only cables and electrodes supplied by device manufacturer IACER S r l 8 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION Electrodes must not be used when they no longer stick to the skin Repeated use of the same electrodes can compromise the safety of the stimulation in fact it can cause skin redness that can last for many hours after stimulation The manufacturer is responsible of the performances safety and integrity of the device only if Eventual additions modifications and or reparations are performed by authorized personnel The electrical system is in compliance with the national laws The device is used in compliance with the instructions of the user manual Electromagnetic Interference The device does not generate and does not receive interference from other equipment It should still use the device while holding the applicator at a distance of at least 3 meters away from televisions monitors cell phones or any other electro
7. and menicar oivision logos are owned by LA C E R S r l and are registered IACER S r l 23 of 24 MNP151 Rev 00 21 07 14 I TECH EMC Tabels Aspetti di emissione Prova di emissione Conformita Ambiente elettromagnetico guida e Gruppo 1 Il dispositivo utilizza energia RF solo per il suo Emissioni RF Pp f nzionamento interno A Cispr 11 Perci le sue emissioni RF sono molto basse e verosimilmente non causano interferenze negli apparecchi elettronici vicini ia Classe B Il dispositivo adatto per l uso in tutti gli edifici Emissioni RF diversi da quelli domestici e da quelli collegati Cispr 11 direttamente ad una rete di alimentazione a bassa tensione che alimenta gli edifici per uso domestico E possibile utilizzare l apparecchio in tutti gli edifici compresi gli edifici domestici e quelli direttamente collegati alla rete di alimentazione pubblica in bassa tensione che alimenta edifici per usi domestici Emissioni armoniche IEC 61000 3 2 Non applicabile Non applicabile Aspetti di immunit Il prodotto dispositivo previsto per funzionare nell ambiente elettromagnetico sotto specificato Il cliente o l utilizzatore dovrebbe assicurarsi che esso venga usato in tale ambiente Prova di immunit Livello di prova Livello di Ambiente elettromagnetico EN 60601 1 2 conformit guida Scariche elettrostatiche 6kV a contatto 6kV a contatto pavimenti devono es
8. immediate Adjust the intensity for moderate muscle solicitation Two treatments per day for three or four days Program duration 30 minutes Position of electrodes from photo 1 to 28 TENS 10 Hand and wrist pain This program is suitable for all types of hand and wrist pain aching caused by strains arthritis in the hand carpal tunnel syndrome etc Total program duration 40 minutes A combination of various types of square wave impulses has a general analgesic effect on the area to be treated impulses at different frequencies stimulate different sized nerve fibres promoting an inhibitory action at spinal level The intensity should be adjusted to a level between the thresholds of perception and pain without causing muscle contraction Position of electrodes form a square above the area to be treated as shown in illustration 1 TENS 11 Plantar stimulation This program has a relaxing and draining effect on the limb stimulated It is ideal for people suffering from a sense of heaviness in the legs Duration 40 minutes Intensity just above the threshold of perception Position of electrodes 2 electrodes one positive the other negative on the sole of the foot one close to the toes the other under the heel IACER S r l 15 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION TENS 12 Epicondylitis Also known as tennis elbow it is an insertional tendinopathy concerning insertion of the elbow bone into
9. used drug can have negative polarity positive polarity or double polarity The current induce the drug to run from one pole to the other crossing the painful area and releasing the specific active ingredient WARNING before starting the therapy wet the sponge electrodes and wring them so to avoid dripping then put the drug on the electrode as follow e Active polarity drug dissolve this drug on the electrode connected to positive pole red connectot e Negative polarity drug dissolve this drug on the electrode connected to negative pole black connector IACER S r l 10 of 24 MNP151 Rev 00 21 07 14 MEDICAL DIVISION e Double polarity drug can be dissolved on positive pole or negative pole without distinction Position the electrode with the drug on painful area and the other electrode on the other side At the end of the program the skin could lightly turn bright red the reddening usually vanishing few minutes after the end of program WARNING Do not use ionophoresis program near metallic prosthesis LIST of the main drugs used in ionophoresis Drug Polarity Pharmaceutical Indications action Calcium chloride Positive Sedative and Osteoporosis recalcifying Spasmophilia Sol 1 2 algodystrophic syndrome DO not use in cases of arteriosclerosis Magnesium chloride Positive Analgesic sedative Substitute fot calcium o chloride cases with Sol 10 Fibrolytic arteri
10. 90 min frequency 1 200 Hz M11 M12 contraction time 1 10 sec slope 0 5 sec Recovery time 0 30 sec impulse width 50 450us M13 Battery Test M1 M5 TENS Free memories Free memories for antalgic TENS treatment M6 M10 NEMS Free memories Free memories for muscle recovery and training M11 M12 NEMS Alternated free memories Free memories for muscle recovery and or training with alternated impulses on channel 1 and 2 M13 Battery test program only for I A C E R assistance centre Program for battery test IACER S r l 20 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION Maintenance Battery charging Display will show low battery indicator J only when battery is low In this case it may not be possible to undertake the therapy session or not being able to complete it To proceed with the charging follow the steps below e Make sure that the device is switched off or switch off the device pressing the O OK button Connect the battery charger to the plug of the unit and connect the battery charger into the power socket The display will show the battery blinking icon 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 Battery replacement To proceed with battery replacement follow the steps below Remove the clip belt e Open the b
11. EDICAL DIVISION MNPG151 Rev 0 del 21 07 14 Electrotherapy model MIO IONOTENS I TECH IACER S r l 2 of 24 MNP151 Rev 00 21 07 14 I TE MEDICAL DIVISION Summary Technical Specifications Manufacturer Declaration of Conformity Purpose Specifications Labelling Labelling details Symbol description Contents of the package How to use Warning Electromagnetic Interference Contraindications How to use TENS and ionophoresis Programs list Maintenance Battery charging Battery replacement Cleaning Cartiage and storage Disposal Troubleshooting Assistance Spare parts Warranty EMC Tabels IACER S r l 3 of 24 0 0 N A VI A AS RW 21 21 21 21 21 22 22 22 22 23 24 MNP151 Rev 00 21 07 14 I TECH Technical Specifications Manufacturer I A C E R S r l Via S Pertini 24 a 30030 Martellago VE Tel 041 5401356 Fax 041 5402684 IACER S r l is an Italian medical devices manufacturer CE medical certificate n MED 24021 Declaration of Conformity IACER S r l headquartered in Italy via S Pertini 24 A 30030 Martellago VE declares on its own responsibility that MIO IONOTENS is manufactured in conformity with Council Directive 93 42 EEC MDD dated 14 June 1993 D Lgs 46 97 dated 24 February 1997 Attuazione della Direttiva 93 42 CEE concernente i dispositivi medici Annex II as modified by Directive 2007 47 CE dated 5 September 2007 D Lgs 37 2010 dated
12. EM by pressing MODE ESC button Scroll the programs using PRG and PRG buttons Read the following instructions to adjust the program parameters time frequency and width impulse 2 PARAMETERS ADJUSTEMENT e Adjust therapy time TIME min pressing A increase and W decrease CH1 or CH2 buttons Press SET to confirm e Adjust frequency Hz pressing A increase and W decrease CH1 or CH2 buttons Press SET to confirm Adjust width impulse us pressing A increase and W decrease CH1 or CH2 buttons Press OK to confirm 3 INTENSITY ADJUSTEMENT Increase intensity current of two channels using CH1 and CH2 A buttons The value can be adjusted with 1mA stepping Decrease the intensity pressing W buttons TENS and ionophoresis In TENS programs 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 area treated begin to contract It is suggested to stop before that point The electrodes should be positioned to form a square surrounding the painful area using Channel 1 and Channel 2 as shown in illustration 1 Red ZN WARNING Painful Cha nell area Channel 2 Apply the electrodes forming a square over the painful area while maintaining a minimum distance of 4cm between Black Black an electrode and the other For ionophoresis programs set up an intensity value so to have pins and needles on treatment area The
13. NOTENS thanks to its protocols TENS is particularly suitable for the treatment of pain TENS pulses are able to significantly reduce and in some cases eliminate the sensation of pain caused by diseases and or problems indicated above MIO IONOTENS has also specific ionophoresis protocols Ionophoresis is an electrotherapeutic technique that uses continuous current to introduce drugs on pain or contracture area The current promotes the migration of the drug ions the drug passes through the pain area releasing its specific action lonophoresis has two great advantages it avoids the administration of drugs by mouth and its treats directly the pain areas Ionophoresis is also used for the treatment of diseases affecting urogenital male apparatus like IPP Induratio Penis Plastic or La Peyronie disease Consult a specialist before start the therapy Contact the manufacturer for other information Specifications Power supply Charger Insulation class CEI EN 60601 1 Applied part CEI EN 60601 1 Dimensions mm Max output current Waveform Waveform frequency Hz Impulse width us Timer Rechargeable battery pack 4 8V 800mAh Input 100 240VAC 50 60Hz 0 2A output 6 8VDC 0 3A I BF 140x70x30 40mA su 1KQ for each channel on REHA programs 99mA su IKQ for each programs on the other programs Quadra compensated biphasic and monophasic square From 0 25 to 200 From 20 to 450 From 1 to 90 minutes WARNING The equipment deliv
14. ale massima del trasmettitore W Da 150kHz a 80MHz Da 80MHz a 800MHz Da 800MHz a 2GHz d 1 2 VP d 1 2 XP d 2 3 VP 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 73 100 12 12 23 Per i trasmettitori con potenza nominale massima di uscita sopra non riportata la distanza di separazione raccomandata d in metri m pu essere calcolata usando l equazione applicabile alla frequenza del trasmettitore ove P la potenza massima nominale d uscita del trasmettitore in Watt W secondo il costruttore del trasmettitore Nota 1 A 80 MHz e 800 MHz si applica l intervallo della frequenza pi alta 2 Queste linee guida potrebbero non applicarsi in tutte le situazioni La propagazione elettromagnetica influenzata dall assorbimento e dalla riflessione di strutture oggetti e persone IACER S r l 25 di 28 MNPG151 Rev 00 21 07 14 1 A C E R S r l Sede operativa 30030 Martellago VE Via S Pertini 24 A Tel 39 041 5401356 Fax 39 041 5402684 Sede legale S Marco 2757 30124 Venezia Cod Fisc P IVA IT 00185480274 R EA VEN 120250 M VE001767 Cap Soc 110 000 00 i v www iacer it iacer iacer it
15. and calcify If neglected this condition can become heavily crippling For this reason after carrying out a cycle of 15 20 applications once a day we recommend that you consult your doctor for a cycle of specific rehabilitation exercises to reduce the pain The Tens17 program consists of various phases including Tens and muscle stimulation aimed at improving the tone of the muscles surrounding the joint Program duration 41 minutes intensity set above the threshold of perception with small muscle contractions at the end of the program 10 minutes before the end ARTHROSIS Arthrosis is a chronic degenerative medical condition appearing insidiously developing over time and causing progressive degeneration of the joints a joint is formed of two or more joint heads cartilage ligaments a synovial membrane a joint capsule tendons and muscles limiting joint motility increasingly over time Arthrosis mainly causes progressive deterioration of cartilage which is not capable of re forming and bone with secondary deformation of the same and production of excrescences called osteophytes which mechanically obstruct joint movement it also causes the joint capsule to thicken and stiffen which together with contraction of the muscles surrounding the joint limits the joint excursion even further Tens therapy can lessen the pain caused by this condition but cannot cure it Tens Tens 1 can be combined with stimulation of the area to be t
16. attery compartment e Disconnect the cable and take away the battery e _ Connect the cable of the new battery e Close the battery compartment and insert the belt clip It is recommended to remove the battery in case of prolonged inactivity Batteries have to be handled by adult persons keep them out of children s reach Dispose the battery according to the current regulations ATTENTION the life of the battery depends on the number of charge recharge cycles We suggest the following precautions for a battery longer duration e Recharge the battery once in a month even if the device is not used Discharge the battery as much as possible before the recharging e 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 Cleaning Clean the equipment from the dust using a soft cloth Resistant stains can be removed using a sponge soaked in solution of water and alcohol Device not subjected to sterilization Carriage and storage Precautions for transportation MIO IONOTENS is a portable device so it does not need any particular carriage precautions However we recommend to put away MIO IONOTENS and its accessories in their own bag after every treatment Storage precautions MIO IONOTENS is protected till following environmental conditions In operation Temperature from 5 to 40 C IACER S r l 21 of 24 MNP151 Rev 00 21 07 14 I TECH R
17. ave impulses has a graduated draining effect on the area to be treated impulses at different frequencies drain the area at different depths The intensity should be adjusted to a level between the thresholds of perception and pain without causing muscle contraction Position of electrodes form a square above the area to be treated as shown in illustration 1 REHA 6 Oedema Program similar to REHA 5 Intensity should be adjusted to a level between the thresholds of perception and pain without muscle contractions Position of electrodes form a square above the area to be treated as shown in illustration 1 REHA 7 TENS sequential During stimulation this program modifies by itself the frequency and impulse width This results in a more comfortable stimulation compared to the one with constant frequency and width impulse Program indicated for pain treatment and massage effect on muscles as trapezium Position of electrodes form a squate above the area to be treated as shown in illustration 1 REHA 8 TENS Burst This program produces a TENS training effect using the frequencies of conventional TENS Useful for pain therapy The action is similar to the one of endorphinic TENS Position of electrodes form a squate on the painful area as shown in illustration 1 REHA 9 Atrophy prevention Program created to maintain muscle trophism This treatment concentrates on muscle toning paying particular attention to slow twitch fibres
18. creases arterial flow and consequently aids the removal of algogenic substances and helps to restore normal physiological conditions Treatment duration 30 minutes in a single phase daily frequency Do not position the electrodes close to inflamed areas Intensity adjusted for good solicitation of the part stimulated the sensation must be similar to that of a massage TENS 3 TENS at maximum values Very short duration 3 minutes Blocks pain impulses peripherally creating a proper anaesthetising effect in the area treated This type of stimulation is suitable for injuries or bruises when rapid action is required The intensity selected is the maximum tolerable value well in excess of conventional tens and therefore with considerable contraction of the muscles surrounding the arca treated That is the reason why such stimulation is undoubtedly the least tolerated but is extremely effective This type of stimulation is not recommended for particularly sensitive people and in any case the electrodes should not be positioned in sensitive areas such as the face and genitals or close to wounds Position of electrodes form a square above the painful area as shown in illustration 1 TENS 4 Anti inflammatory Program tecommended for inflammatory conditions To be applied until the inflammatory state is lessened 10 15 applications once a day the daily treatments can be doubled if required Identify the area to be treated and position the ele
19. ctrodes as shown in illustration 1 Adjust the intensity until a tingling feeling is produced in the area treated avoid contracting the surrounding muscles Program duration 30 minutes TENS 5 Neck pain Headache Specific program for the treatment of pain in the neck arca 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 area treated begin to contract over this limit stimulation does not become more effective just more irritating so it is best to stop before that point 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 Position of electrodes photo 25 Warning the device varies stimulation parameters during the program The current may feel 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 TENS 6 Backache Sciatic pain IACER S r l 14 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION 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 area treated begin to contract
20. el humidity from 30 to 75 Pressure from 700 to 1060 hPa Inside of the packaging Temperature from 5 to 55 C Rel humidity from 10 to 90 Pressure from 700 to 1060 hPa Disposal The equipment is subjected to WEEE regulations see the symbol mmm on the label concerning separate waste collection when disposing this product please use the designed areas for disposing electronic waste or contact the manufacturer Troubleshooting If it is used in accordance with the instructions of the user manual MIO IONOTENS does not need a particular regular maintenance If you find any malfunctioning using MIO IONOTENS please follow these instructions MIO IONOTENS does not turn on and or the display does not light up Check the battery status and replace it if it is necessary make reference to chapter Battery replacement If the problem persists contact the manufacturer e MIO IONOTENS does not transmit electric impulses Check that the cable jacks have been inserted in the electrodes and that the plastic protection has been removed from the electrode Check that the cables have been connected correctly connector well inserted in the device Check that the cables and the electrodes are not damaged If the problem persists contact the manufacturer e MIO IONOTENS transmits low intensity or intermittent impulses Check the cables and the electrodes are in good condition and replace them if it is necessary If the problem persists contact
21. ers current in excess of 10mA IACER S r l 5 of 24 MNP151 Rev 00 21 07 14 I TECH Labelling 90 00 O 000 1 CHI output 2 CH2 output 3 Battery charger connector 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 IACER S r l 6 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION 1 Mode operation REHA TENS MEM 2 Wave frequency 3 Wave impulse width 4 Program number 5 CHI intensity 6 CH2 intensity 7 Battery status 8 Therapy time 9 Contraction time 10 Recovery time 11 Up down slope Labelling details f Model MIO IONOTENS I TECH SN 000001 MEDICAL DIVISION Power supply Ni MH rechargeable battery 4 8V 800mAh Output voltage 0 99V at 1000 Ohm load 1 A C E R Srl Via S Pertini 24 A Martellago VE E ITALY CEO ra IACER S r l 7 of 24 MNP151 Rev 00 21 07 14 I TECH Symbol description Keep dry Avoid contact with liquids Product subject to WEEE regulations concerning separate waste collection of electronic equipment Refers to operating instructions Internally powered device with type BF a
22. lues 3 lonophoresis H high 3 Free TENS 3 4 Anti inflammatory 4 Microcurrent 4 Free TENS 4 5 Neck pain headache 5 Hematoma 5 Free TENS 5 6 Backache sciatic pain 6 Oedema 6 Free NEMS 1 7 Sprains Bruises 7 TENS sequential 7 Free NEMS 2 8 Vascularization 8 TENS Burst 8 Free NEMS 3 9 Muscle relaxant 9 Atrophy prevention 9 Free NEMS 4 10 Hand and wrist pain 10 Atrophy 10 Free NEMS5 11 Plantar stimulation 11 Alternated NEMS 1 12 Epicondylitis 12 Alternated NEMS 12 13 Epitroclea 13 Battery test 14 Periarthritis Programs Technical Specifications TENS Programs Prg PHASE 1 PHASE 2 PHASE 3 Total time 40 min T1 frequency 90 Hz impulse width 504s Time tot 30 min T2 frequency 1 Hz impulse width 200us T3 Time tot 3 min IACER S r l 12 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION frequency 150 Hz impulse width 200us Total time 30 min T4 frequency 120 Hz impulse width 504s Total time 20 min Total time 5 min Total time 10 min T5 frequency 90 Hz frequency 2 Hz frequency 90 Hz impulse width 60ps impulse width 150Hus impulse width 60us Total time 20 min Total time 20 min T6 frequency 90 Hz frequency 60 Hz impulse width 50us impulse width 60us Total time 10 min Total time 10 min Total time 10 min T7 frequency 110 Hz frequency 90 Hz frequency 70 Hz impulse width 50us impulse width 50us impulse width 60us Total time 20 min T8 frequency 2 Hz i
23. mpulse width 200us Total time 10 min Total time 10 min Total time 10 min T9 frequency 4 Hz frequency 6 Hz frequency 2 Hz impulse width 250us impulse width 200us impulse width 300us Total time 15 min Total time 15 min Total time 10 min T10 frequency 70 Hz frequency 90 Hz frequency 110 Hz impulse width 60us impulse width 50us impulse width 50us Total time 15 min Total time 15 min Total time 10 min T11 frequency 70 Hz frequency 2 Hz frequency 90 Hz impulse width 60ps impulse width 150us impulse width 50ps Total time 20 min Total time 10 min Total time 10 min T12 frequency 90 Hz frequency 70 Hz frequency 50 Hz impulse width 50us impulse width 60us impulse width 90us Total time 20 min Total time 20 min T13 frequency 90 Hz frequency 70 Hz impulse width 50us impulse width 60us Total time 1 min Total time 30 min Total time 10 min frequency 150 Hz frequency 90 Hz 3Hz 200us x 7sec T14 impulse width 200us impulse width 60us 50 1Hz 200ps x 3 sec 60 30Hz 200us x 5 sec 50 x 40 cycles TENS 1 Conventional TENS Program used for analgesic purposes its purpose is to induce the organism into blocking pain at the spine in accordance with the Gate Control Theory by Melzack and Wall Pain impulses leave part of the body for example the hand and run along the nerve tracts through small diameter nerve fibres until they reach the central nervous system where the impulses ate interpreted as pain Conventional tens activates large diameter ne
24. nic equipment Contraindications Patients in a state of pregnancy tuberculosis juvenile diabetes viral diseases acute fungal dermatitis patients with heart disease arrhythmia or severe with pace makers children denture wearers magnetizable acute infections open wounds epileptics unless otherwise prescriptions There are no known significant side effects In some cases of particularly sensitive people after the treatment of skin rashes occur at the electrodes the redness usually disappears a few minutes after treatment If the redness persists consult a physician In rare cases the stimulation evening causes a delay in falling on some subjects In this case avoid treatment in the evening How to use MIO IONOTENS is a portable and battery powered device that generates TENS and IONOPHORESIS currents It is particularly indicated for daily treatments of the most commons muscle diseases I TECH PHYSIO is provided with two independent and adjustable intensity channels MIO IONOTENS has 14 preadjusted tens programs 10 preadjusted programs REHA including 3 programs iontophoresis and 12 free memories adjustable by the user to create programs according to his needs The program MEM 13 is a battery test PRELIMINARY INSTRUCTIONS 1 CABLES AND ELECTRODES CONNECTION Position the electrodes on the skin see the following paragraph connect the electrostimulation cable jacks to the self adhesive electrodes and then connects the cables t
25. o the outputs on the upper side of MIO IONOTENS 2 SWITCHING ON OF THE DEVICE I Turn MIO IONOTENS on using the O OK button PREADJUSTED PROGRAMS Read the follow instructions to use the preadjusted programs of MIO IONOTENS 1 MENU AND PROGRAM SELECTION Select the menu by pressing MODE button TENS REHA MEM Select the program using PRG and PRG buttons please make reference to Programs list to get all technical specifications 2 INTENSITY SELECTION You can increase current intensity using CH1 and CH2 buttons up arrow The value can be adjusted with stepping of 1 mA Press CH1 and CH2 buttons down arrow to decrease the intensity MIO CARE PRO tecognize the electrodes connection in case of faulty connection when the intensity reaches 10 mA the value is resetted to zero The remaining time is showed on the display of MIO IONOTENS An acoustic signal advises the user when the treatment is completed IACER S r l 9 of 24 MNP151 Rev 00 21 07 14 I TECH SETI II Press the button to pause the treatment To restart the program press O OK button Turn off the device keeping pressed the OK button for at least two seconds The device automatically switches off when no button is pressed for 2 minutes FREE MEMORIES ADJUSTABLE PROGRAMS With I TECH PHYSIO you can set the parameters according to your needs using the MEM programs Read the following instructions to adjust the parameters 1 PROGRAM SELECTION Select M
26. osclerosis Potassium iodide Negative Sclerolytic emollient Scars adhesions Dupuytren s disease cheloidis Lysine acetylsalicylate Negative Analgesic Arthrosis Flectadol Aspegic Negative Analgesic Arthrosis extra intra articular rheumatisms Local anaesthetics Negative Local anaesthesia si trigeminal neuralgia Novocaine lidocaine 8 8 Benzydamine Positive Analgesic Rheumatoid arthritis Diclofenac sodium Positive Negative Analgesic Hematomas Orudis voltaren Negative Anti inflammatory Degenerative and Lometacen Arfen extra articular Tilcotil Axera rheumatisms gout Naprosyn Piroxicam Feldene Positive Analgesic Fractures Sodium salicylate Negative Analgesic Articular rheumatism IACER S r l 11 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION myalgia 1 3 a Ketoprofene Positive Negative Anti inflammatory Arthrosis arthritis Lysine salt Thiomucase Negative Antiedemic Post trauma and post surgical oedema due to venous insufficiency If the drug used is not included in the above list determine the polarity from the package or consult the prescribing doctor or dispensing pharmacist Programs list TENS REHA MEM 1 Conventional Tens 1 Ionophoresis L low 1 Free TENS 1 rapid 2 Endorphinic Tens 2 Ionophoresis M 2 Free TENS 2 delayed medium Tens at maximum 3 va
27. pplied parts 0476 This product complies with the European Community Directive 93 42 EEC and subsequent mod e Manufacturing date month year Contents of the package MI o o o 0 o p_B_ DB Db D_ Db D DDD o To To o o O IONOTENS contains device Rechargeable battery pack 4 8V 800mAh 2 cables for electrical stimulation 4 cable splitters set of 4 pre gelled electrodes 41x41mm alternatively 48x48mm set of 4 pre gelled electrodes 40x80mm alternatively 50x90mm Tontophoresis kit elastic band 2 rubber electrodes 2 sponges belt clip catriage bag User manual Howto use Warning Take care of position and meaning of the labels on MIO LONOTENS Do not damage the connection cables and avoid to roll up the cables around the device Check the device and its accessories before use Avoid the use in case of damage to the case or to the accessories damaged cables contact the manufacturer as mentioned in Assistance paragraph Avoid the use of MIO IONOTENS to people not educated through the reading of the manual Avoid the use of MIO IONOTENS in damp environments Do not wear metallic objects during therapy It is forbidden 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 Use of the device is prohibited with electrodes positioned on or close to injuries or cuts
28. reated using a low frequency current Tens 2 to relax the surrounding muscles IACER S r l 16 0f 24 MNP151 Rev 00 21 07 14 E Q MEDICAL DIVISION Pathology Program No of treatments Treatment Position of frequency electrodes TENS1 Untilpainis Pay TENS1 up to Arthrosis TENS 2 e 2 3 times a day On the painful area mn TENS 2 once a day Daily even twice a z Neck pain TENS 5 0 12 dd Photo 25 day Cervicogenic headache TENS 5 0 12 Daly meea Photo 25 day Photo 25 but with Back pain TENS 6 0 12 Daily all electrodes placed 10 cm lower Backache TENS 6 2 15 Daily Photo 27 Sciatic pain TENS 6 5 20 Daily n mueca Photo 28 Photo 18 with all 5 r DI Daily even twice a electrodes placed on Cruralgia TENS 6 5 20 day the inside of the thigh FR Daily even twice a Epicondylitis TENS 15 5 20 ur Photo 29 dav Hip pain TENS 1 0 20 Daily gua DEE Photo 30 Knee pain TENS 1 0 20 Daily p ricca Photo 31 dav Ankle sprain TENS 3 5 7 Daily up to2 3 Photo 32 times a day Carpal tunnel syndrome TENS 1 10 12 Daily Fe Picea Photo 33 dav Trigeminal neuralgia TENS 18 10 12 Daily Photo 24 PIRAS TENS 1 Daily even twice a 7 Wryneck TENS 9 8 10 diy Photo 25 Periarthritis TENS 17 15 20 Daily Photo 26 Important for all of these programs stimulation intensity must be set between the threshold of impulse perception and the moment in which the impulse star
29. rve fibres blocking the path of small diameter nerve fibres at the spine So action is mainly taken against the symptom to simplify it further the wire transmitting pain information is obstructed Treatment duration should be no less than 30 40 minutes Conventional tens is a current that can be used to treat general everyday pain The average number requited to benefit from the treatment is 10 12 per day there are no contraindications for up to double this amount The program has a duration of 40 minutes in a single phase The program can be repeated at the end of the session for particularly persistent pain The nature of the impulse means that the patient may IACER S r l 13 of 24 MNP151 Rev 00 21 07 14 I TECH experience an addictive effect due to which the impulse will be felt less and less if necessary the intensity can be increased by one level to counter this effect Position of electrodes form a square above the painful area as shown in illustration 1 TENS 2 Endorphinic TENS This type of stimulation produces two types of effects according to how the electrodes are positioned positioning the electrodes in the dorsal region see photo 08 in the positions manual promotes the endogenous production of morphine like substances capable of raising the pain perception threshold positioning the electrodes to form a square above the painful area as shown in illustration 1 produces a vascularizing effect Vascularization in
30. sere in legno ESD 8KV in aria 8kV in aria calcestruzzo o in ceramica Se i EN 61000 4 2 pavimenti sono ricoperti di materiale sintetico l umidit relativa dovrebbe essere almeno del 30 Transitori treni elettrici Non applicabile Non applicabile Non applicabile veloci EN 61000 4 4 Impulsi Non applicabile Non applicabile Non applicabile EN 61000 4 5 Buchi di tensione brevi interruzioni e variazioni di tensione sulle linee di ingresso EN 61000 4 11 Non applicabile Non applicabile Non applicabile Campo magnetico alla 3 A m 3 A m campi magnetici a frequenza di rete frequenza di rete dovrebbero avere livelli caratteristici di EN 61000 4 8 una localit tipica in ambiente commerciale o ospedaliero IACER S r l 24 di 28 MNPG151 Rev 00 21 07 14 I TECH MEDICAL DIVISION Aspetti di immunit a r f Il dispositivo previsto per funzionare nell ambiente elettromagnetico sotto specificato Il cliente o l utilizzatore dovrebbe assicurarsi che esso venga usato in tale ambiente Prova di immunit Livello di prova Livello di Ambiente elettromagnetico guida EN 60601 1 2 conformit RF Condotta 3 Veff da 150kHz 3 Veff da 150kHz Gli apparecchi di comunicazione a RF portatili e EN 61000 4 6 a 80MHz a 80MHz mobili non dovrebbero essere usati vicino a RF Radiata 3 Veff da 80MHz 3 Veff da 80MHz nessuna parte dell apparecchio compresi i cavi EN 61000 4 3 a 2 5GHz a
31. the manufacturer e MIO IONOTENS switches off during the operation It is suggested to replace the battery and start a new treatment If the problem persists contact the manufacturer e 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 Assistance Every intervention on device must be performed by manufacturer For any assistance intervention contact the National Distributor or the manufacturer at the following address LA C E R S r l Via S Pertini 24 a 30030 Martellago VE Tel 041 5401356 Fax 041 5402684 Technical documentation concerning the spare parts can be supplied by the manufacturer but only prior business authorization and specific training Spare parts For original spare parts contact the National Distributor or the manufacturer at following address LA C E R S r l Via S Pertini 24 a 30030 Martellago VE Tel 041 5401356 Fax 041 5402684 To preserve product warranty functionality and product safety we recommend to use only original spare parts IACER S r l 22 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION Warranty Make reference to the national laws for any warranty conditions by contacting the national distributor or directly the manufacturer IACER m O MIO IONOTENS All rights reserved MIO IONOTENS
32. the epicondylar muscles those enabling finger and wrist extension bending backwards 15 applications once a day even twice until the symptoms pass We recommend that you consult your doctor to identify the precise cause of the pain in order to prevent the condition from reoccutring Program duration 40 minutes intensity adjusted above the threshold of perception Position of electrodes photo 29 TENS 13 Epitroclea 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 epitroclea Pain is felt when bending or straightening the wrist against resistance or when clenching a hard rubber ball in the hand 15 applications once a day even twice until the symptoms pass We recommend that you consult your doctor to identify the precise cause of the pain in order to prevent the condition from reoccurring Program duration 40 minutes intensity set above the threshold of perception Position of electrodes photo 29 but with all of the electrodes positioned on the inside of the arm with a rotation of about 90 TENS 14 Periarthritis Scapulo humeral periarthritis is an inflammatory condition affecting the fibrous tissues surrounding joints tendons serous sacs and connective tissue These appear altered and can break into fragments
33. ts to cause discomfort With the exception of the periarthritis program the muscles surrounding the area to be treated must not contract they should only produce slight vibrations IACER S r l 17 of 24 MNP151 Rev 00 21 07 14 I TECH MEDICAL DIVISION REHA Programs Prg PHASE 1 PHASE 2 PHASE 3 Total time 30 min RI frequency 800 Hz impulse width 100us Total time 30 min R2 frequency 1000 Hz impulse width 100us Total time 30 min R3 frequency 1200 Hz impulse width 100us Total time 30 min R4 frequency 90 Hz impulse width 20us Total time 30 min 5 sec 30 Hz 200 us 5 sec 50 Hz 150 us 5 sec 100 Hz 120 us x 120 cycles R5 Total time 30 min 6 sec 100Hz 175 us 6 sec 2 100Hz modulated 250 us 6 sec 150Hz 60 200 us R6 Total time 30 min 6 sec 100Hz 175 us 6 sec 2 R7 100Hz mod modulated 250 us 6 sec 150Hz 60 200 us modulated Total time 30 min frequency 2 Hz impulse width 80 us Burst impulses R8 Total time 4 min Total time 10 min Total time 10 min frequency 6 Hz 10 sec 3Hz 250us 80 5 10 sec 3Hz 250us impulse width 250us sec 20Hz 250us 80 x 40 80 5 sec 30Hz cycles 250us 80 x 40 cycles R9 Total time 4 min Total time 10 min Total time 10 min frequency 6 Hz 10 sec 3Hz 250us 80 5 10 sec 3Hz 250us impulse width 250us sec 40Hz 250us 80 x 40 80 5 sec 50Hz
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