MNPG152-03 - I-Tech Medical Division
Contents
1. impulse 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 60us impulse width 150us impulse width 50us 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 impulse width 200us impulse width 60us 50 1Hz 200us x 3 sec 60 30Hz 200us x 5 sec 50 x 40 cycle T14 TENS 1 Conventional Tens Program used to relieve pain its action is to induce a body block pain at a spinal level as claimed by the gate theory of Melzack and Wall The pain impulses that start at a given point of the body such as a hand run through the nerve pathways via nerve fibers of small diameter to reach the central nervous system where the impulse is interpreted as pain The conventional TENS2. RAMP 66 GB 8 1 Mode operation URO TENS MEM 2 Wave frequency 3 Wave impulse width 4 Program number 5 CHI intensity 6 CH2 intensity T Battery status 8 Therapy time 9 Contraction time 10 Recovery time 11 Up down slope Labelling details I T Model MIO PERISTIM 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 ITALY SN 000001 MEDICAL DIVISION CAM S 9 8808 IACER S r l 7 of 24 MNP152 Rev 03 03 07 15 I TECH Symbol description ane Keep dry Avoid contact with liquids Product subject to WEEE regulations concerning separate waste collection of electronic equipment Tot tonni Follow the instructions Applied part type BF C Euz Compliance with Directive 93 42 EEC MDD and following modifications Manufacturing date month year Kit contents n 1 MIO PERISTIM n 1 battery pack n 2 cables for electrical stimulation n 4 cable splitters n 1 set of 4 pre gelled electrodes 41x41mm alternatively 48x48mm n 1 set of 4 pre gelled electrodes 40x80mm alternatively 50x90mm n 1 belt clip n 1 carry bag n 1 User manual n 1 electrodes position manual n 1 optional accessory e n 1 anal probe e n 1 vaginal probe How to use Warnings e
3. 1 produces an effect vascularizing The action of vascularization produces an increase in blood flow resulting in a positive effect on the removal of substances algogenic and a restoration of normal physiological conditions Duration of treatment 30 minutes in a single stage daily frequency Do not place the electrodes in close proximity to areas prone to inflammation Intensity adjusted so as to produce a good part of the stress stimulated the feeling must be similar to a massage TENS 3 TENS at maximum values Very short duration 3 minutes It inhibits pain impulses peripherally causing a real local anesthetic effect It a suitable type of stimulation in situations of trauma or bruising where you need to intervene quickly The intensity selected is the maximum tolerable well beyond the limits of conventional TENS so with conspicuous contraction of the muscles surrounding the treated area For this reason this stimulation is certainly the least tolerated but very effective It is a type of stimulation that is not recommended for people who are particularly sensitive and in any case to avoid placing the pads in sensitive areas like the face genitals near wounds Location electrodes forming a square over the painful area as Figure 1 TENS 4 Anti inflammatory Recommended program in inflammatory states Application to the reduction of the inflammatory state 10 15 applications 1 time per day with the possibility of doubling the
4. 800MHz to 2GHz d 1 2 VP 800MHz d 2 3 VP d 12 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 7 3 100 12 12 23 IACER S r l 24 of 24 MNP152 Rev 03 03 07 15 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 VA IT 00185480274 R EA VEN 120250 M VE001767 Cap Soc 110 000 00 i v www iacer it iacer iacer it
5. Take care of position and meaning of the labels on MIO PERISTIM e Do not damage connection cables and avoid to roll up the cable around the device e 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 e Avoid the use of the device to people not educated through the reading of the manual e Do not use MIO PERISTIM in damp environments e Do not wear metallic objects during therapy e Itis 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 e Use of the device is prohibited with electrodes positioned on or close to injuries or cuts IACER S r l 8 of 24 MNP152 Rev 03 03 07 15 I TECH e The electrodes must not be positioned on the carotid sinuses carotid or genitals e 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 e Insufficienty sized electrode sections can cause skin reactions or burns e Do not use electrodes when damaged even if they stick to the skin well e Use only cables and electrodes provided by the manufacturer e Electrodes must not be used when th
6. activates nerve fibers of large diameter at the spinal level blocking the path of the fibers of small diameter And therefore an action primarily on symptom To further simplify the occluded is the thread that carries the information of pain The duration of treatment should not be less than 30 40 minutes The conventional TENS is a current that can be used in the treatment of daily pain in general The number of treatments required for an average experience of the benefits is 10 12 on a daily basis no contraindication to double the dose The program has a duration of 40 minutes in a single step In case of persistent pain particularly at the end of a session to repeat the program For the particularity of the pulse during treatment you may experience an effect of addiction that he will feel less and less impulse to counteract this effect it is sufficient as needed to increase the intensity level IACER S r l 13 of 24 MNP152 Rev 03 03 07 15 I TECH Location electrodes form a square above the painful area as Figure 1 TENS 2 Endorphinic TENS This type of stimulation produces two effects in relation to the placement of the electrodes by placing the electrodes in the dorsal area with reference photos of the 08 positions manual promotes the production of endogenous morphine like substances that have the ability to raise the threshold of pain perception positioning electrodes forming a square over the painful area as Figure
7. daily treatments Having identified the part to be treated as square to place the electrodes Fig 1 The intensity should be adjusted so as to produce a slight tingling on the treated area avoiding the contraction of the surrounding muscles Duration of program 30 minutes TENS 5 Neck pain headache Specific program for the treatment of pain in the cervical area Duration 35 minutes Intensity adjusted between the perception threshold and the threshold of pain the maximum intensity is represented by the time when the musculature surrounding the treated area begins to contract beyond this limit the stimulation does not increase its effectiveness but only the sense of annoyance so it s good to pause before this threshold The number of treatments to achieve the initial benefits is between 10 and 12 daily continue in treatment until the symptoms have disappeared Position of electrodes photo n 25 IACER S r l 14 of 24 MNP152 Rev 03 03 07 15 I TECH Note During the program the unit varies the parameters of stimulation You may have feelings of current different what is normal and expected in the software To raise or decrease the intensity according to their sensitivity to reach the comfort of their own stimulation TENS 6 Backache sciatic pain Specific program for the treatment of pain in the lumbar area or along the sciatic nerve or both Intensity adjusted between the perception threshold and the threshold of pain the maximu
8. difficulty in falling asleep If this occurs suspend the treatment and consult a doctor How to use MIO PERISTIM is a portable and battery powered device that generates TENS and perineal rehabilitation currents It is particularly indicated for muscle pain and for the treatment of urinary and faecal incontinence MIO PERISTIM has two independent channels adjustable by the uset MIO PERISTIM has 14 stored TENS programs 9 URO programs and 12 free memories that can be adjusted by the user to create programs according to specific needs MEM 13 program is for battery test PRELIMINARY INSTRUCTIONS 1 ELECTRODES AND CABLES CONNECTION IACER S r l 9 of 24 MNP152 Rev 03 03 07 15 I TECH Place the electrodes on the skin near the painful area see next chapter for details connect the electrodes to the cables and then connect the cables to CH1 and CH2 outputs on the upper side of MIO PERISTIM 2 SWITCHING ON I Switch on the device pressing O OK button STORED PROGRAMS Read the following instructions if you want to use stored programs on MIO PERISTIM 1 PROGRAM SELECTION Press MODE button to select the treatment TENS URO MEM Select the program using PRG e PRG buttons for the features of each program make reference to the paragraph List of Programs 2 INTENSITY ADJUSTEMENT 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 dow
9. headache Urinary incontinence 5 Free TENS 5 by urge 2 6 Backache sciatic pain Urinary incontinence el Free NEMS i by urge 3 Mixed urinary Free NEMS 2 7 Sprains Bruises incontinence and fecal 7 1 en Mixed urinary 8 Free NEMS 3 incontinence 2 9 Muscle relaxant Mixed utinary 9 Bree NEMS 4 incontinence 3 10 Hand and wrist pain 10 Free NEMS 5 11 Plantar stimulation 11 NEMS alternated 1 12 Epicondylitis 12 NEMS alternated 2 13 Epitroclea Battery test 14 Periarthritis Program Technical Specifications TENS programs Prog PHASE 1 PHASE 2 Total time 40 min T1 frequency 90 Hz impulse width 50us Total time 30 min T2 Frequency 1 Hz impulse width 200us Total time 3 min T3 Frequency 150 Hz impulse width 200us Total time 30 min T4 Frequency 120 Hz impulse width 50p1s Total time 20 min Total time 5 min Total time 10 min T5 Frequency 90 Hz Frequency 2 Hz Frequency 90 Hz impulse width 60us impulse width 150us impulse width 60ps T6 Total time 20 min Total time 20 min Frequency 90 Hz Frequency 60 Hz IACER S r l 12 of 24 MNP152 Rev 03 03 07 15 MEDICAL DIVISION impulse width 60us T7 impulse width 50us Total time 10 min Frequency 110 Hz impulse width 50us Total time 10 min Frequency 90 Hz impulse width 50us Total time 10 min Frequency 70 Hz impulse width 60us Total time 20 min T8 Frequency 2 Hz
10. incontinence and faecal Programs suitable for the treatment of stress urinary incontinence in women and faecal humans only U1 designed to strengthen and tone the muscles of the pelvic floor and perineal who have lost force and contractile capacity or the sphincter muscles with weak contractile capacity The stimulation should be as strong as possible without being painful In addition it helps a patient s participation in acts voluntary muscle during stimulation It is suggested to be associated with the appropriate therapy training exercises for strengthening the muscles themselves Applications 3 5 sessions per week Use the vaginal probe for the treatment of urinary incontinence in women and anal probe for faecal incontinence in both men and women URO 4 5 6 Urge urinary incontinence and faecal This program is suitable for the treatment of urge incontinence in women and faecal humans only U4 Low frequency stimulation that helps to relax the bladder in case of hyperactivity The stimulation should be as strong as possible without being painful In addition it helps a patient s participation in acts voluntary muscle during stimulation Applications 2 5 sessions per week Use the vaginal probe for the treatment of urinary incontinence in women and anal probe for faecal incontinence in both men and women URO 7 8 9 Mixed urinary incontinence and faecal Programs suitable for the treatment of urinary incontinence in women and mixed fae
11. to pelvic floor muscles or to sphincter causing the contractions and strength recovery Thanks to its TENS protocols MIO PERISTIM is particularly suitable for pain therapy TENS impulses can reduce and in many patients eliminate the pain generated from pathologies affecting muscles and tendons Technical specifications Power supply Rechargeable batteries 4 8V 800mAh Charger Input 100 240VAC 50 60Hz 0 2A output 6 8VDC 0 3A Insulation class CEI EN 60601 II 1 Applied part CEI EN 60601 1 BF Dimension mm 140x70x30 Max output current 40mA 1KQ load for channel in REHA programs 99mA 1KQ load each channel for the remaining programs Waveform Biphasic compensated square wave and monophasic square wave Waveform frequency Hz From 1 to 200 Impulse width us From 20 to 450 Timer From 1to 90 minutes WARNING The equipment delivers current in excess of 10mA IACER S r l 5 of 24 MNP152 Rev 03 03 07 15 I TECH Labelling 99 00 2068 1 CHI output 2 CH2 output 3 Battery charger connector 4 Display 5 Increase intensity CH1 6 Decrease intensity CHI 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 MNP152 Rev 03 03 07 15 I TECH O Sag
12. MEDICAL DIVISION USER MANUAL MNPG152 Rev 03 03 07 15 Electrotherapy model MIO PERISTIM I TECH IACER S r l 2 of 24 MNP152 Rev 03 03 07 15 Summary Technical information Manufacturer Declaration of Conformity Classifications Purpose Technical specifications Symbol description Kit contents How to use Warnings Electromagnetic interference How to use TENS and pelvic rehabilitation Programs List Program Technical Specifications Maintenance Battery charging Battery replacement Cleaning Carriage and storage Information for disposal Troubleshooting Assistance Spare Parts Warranty EMC Tables IACER S r l 3 of 24 DM vo oonan AAAA A Q i haa Ne NINNNNNNNNEON OD RP OCS N ies MNP152 Rev 03 03 07 15 I TECH MEDICAL DIVISION Technical information Manufacturer LA 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 PERISTIM is manufactured in conformity with Council Directive 93 42 EEC MDD dated 14 June 1993 D Lgs 46 97 dated 24 February 1997 Implementation of Directive 93 42 CEE concerning medical devices Annex II as modified by Directive 2007 47 CE dated 5 S
13. battery test Maintenance Battery charging Display will show low battery indicator td 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 IACER S r l 20 of 24 MNP152 Rev 03 03 07 15 I TECH e 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 e Remove the clip belt e Open the battery 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 ba
14. cal humans only U7 The stimulation should be as strong as possible without being painful In addition it helps a patient s participation in acts voluntary muscle during stimulation It is suggested to be associated with the appropriate therapy training exercises for strengthening the muscles themselves Applications 3 5 sessions per week Use the vaginal probe for the treatment of urinary incontinence in women and anal probe for faecal incontinence in both men and women MEM Programs Prog PHASE 1 Free memories TENS MEMS Total time 1 90 min IACER S r l 19 of 24 MNP152 Rev 03 03 07 15 a 14 Frequency 1 200 Hz Impulse width 20 250 us Free memories NEMS Total time 1 90 min Frequency 1 200 Hz M6 M10 Contraction time1 10 sec slope 0 5 sec recovery time 0 30 sec Impulse width 50 450pus Free memories NEMS alternated on channel 1 and 2 Total time 1 90 min M11 Frequency 1 200 Hz M12 Contraction time11 10 sec slope 0 5 sec recovery time 0 30 sec Impulse width 50 450ps M13 Battery test program M1 M5 TENS Free memories Free memories for antalgic TENS treatment M6 M10 NEMS Free memories Free memories for muscle recovery and ot training M11 M12 NEMS Alternated Free memories Free memories for muscle recovery and or training with alternated impulses on channel 1 and channel 2 M13 Battery test program only for I A C E R assistance centre Program for
15. ception Position of electrodes 2 electrodes one positive the other negative on the sole of the foot near the toes of one foot the other under the heel TENS 12 Epicondylitis Also known as tennis elbow is an insertional tendinopathy involving the insertion of the bone of the elbow epicondylar muscles which are those that allow the extension bending backwards of the fingers and wrist 15 applications once a day even 2 times until disappearance of the symptoms In general it is advisable to consult your doctor to check the precise source of pain in order to avoid the recurrence of the disease Program duration 40 minutes adjusted intensity above the threshold of perception Position of electrodes photo 29 TENS 13 Epitroclea Also known as golfer s elbow affecting not only golfers but also those who perform repetitive tasks that involve frequent or intense efforts for example carry a very heavy suitcase You feel pain in the tendons and flexor pronator inserted sull epitroclea It s a pain that is felt when bending or prone wrist against resistance or when clutches a hard tubber ball 15 applications once a day even 2 times until disappearance of the symptoms In general it is advisable to consult your doctor to check the precise source of pain in order to avoid the recurrence of the disease Program duration 40 minutes adjusted intensity above the threshold of perception Location electrodes photo 29 but with
16. e stimulation As reported in the tables relating to the programs we advise you to associate with electro stimulation therapy appropriate training exercises that help the recovery of strength and muscle tone of the pelvic floor muscles It is precisely the weakening of the muscles that leads to the onset of disorders such as urinary incontinence and urogenital prolapse Strengthening this muscle produces incredible improvements in symptoms of urinary incontinence and genital prolapse also blocking the advance of dysfunction The pelvic floor rehabilitation must be the first line treatment in women with stress incontinence It is important to stress that these exercises should be taught to the patient by a specialist doctor physiotherapist midwife This exercise involves the contraction of the vaginal and anal muscles without the use of the abdominal muscles and buttocks The exercises are then repeated in different patterns always follow the doctor s orders Programs List TENS URO MEM Stress urinary 1 ana TENS 1 incontinence and fecal 1 Free TENS 1 rapid 1 2 Endorphinic Tens 2 Stress urinary 2 Free TENS 2 IACER S r l 11 of 24 MNP152 Rev 03 03 07 15 I TEGE MEDICAL DIVISION delayed incontinence 2 3 TENS at maximum Stress urinary 3 Free TENS 3 values incontinence 3 A Urinary and fecal 4 Free TENS 4 incontinence by urge 1 5 Neck pain
17. eptember 2007 D Lgs 37 2010 dated 25 January 2010 Notified Body Cermet Via di Cadriano 23 40057 Cadriano di Granarolo BO ITALY MIO PERISTIM is a Class Ila equipment with reference to Directive 93 42 EEC MDD annexed IX rule 9 and following modifications Certification Path Annex II Martellago 01 07 2014 Legal representative Mario Caprara gt Classifications MIO PERISTIM has the following specifications Class Ha equipment Directive 93 42 EEC annexed IX rule 9 and following modifications e Class II applied part type BF Classif EN 60601 1 e Equipment not protected against liquids penetration e Equipment and accessories not subjected to sterilization Use of the equipment is prohibited close to flammable substances when mixed with air or with oxygen or with nitrous oxide Continuous operating mode equipment e Equipment not suited to be used in external IACER S r l 4 of 24 MNP152 Rev 03 03 07 15 I TEGN Purpose Clinical purpose Therapeutic Scope of use ambulatory and domestic MIO PERISTIM is a stimulator designed and engineered for the treatment of pathologies affecting urogenital system like urinary or faecal incontinence The treatment of incontinence is possible using protocols with specific waveforms frequency and impulse width A probe vaginal probe for urinary incontinence in women anal probe for faecal incontinence both for men and women transmits the impulses
18. ey 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 e Eventual additions modifications and or reparations are performed by authorized personnel e The electrical system is in compliance with the national laws e The device is used in compliance with the instructions of the user manual Electromagnetic interference The device does not produce and receive any interferences from others equipment However it is recommended the use of the device at least 3 metres away from televisions monitors mobile phones or any other electronic equipment Contraindications Patient in pregnancy tuberculosis juvenile diabetes viral in acute phase illnesses mycosis dermatitis cardiopathic subjects serious arrhythmias or pacemaker carriers children metallic prosthesis carriers acute infections epileptics different medical prescriptions excepted No significant side effects are known of Some particularly sensitive people have reported skin redness in the area where the electrodes were positioned the redness usually disappears a few minutes after the end of the treatment Should the redness persist please consult a doctor In rare cases stimulation carried out in the evening can cause some people to experience
19. he threshold of slight discomfort Duration of program 20 minutes Position of electrodes refer to the picture of the positions from 25 to 33 photos TENS 9 Muscle relaxant Program shown to accelerate the process of functional recovery of the muscle after an intense workout or an effort to work performs an immediate action Intensity adjusted so as to ptoduce a discrete solicitation muscle Two daily treatments for three or four days Programme duration 30 minutes Position of electrodes photos from 1 to 28 TENS 10 Hand and wrist pain IACER S r l 15 of 24 MNP152 Rev 03 03 07 15 I TECH This program is recommended in case of pains of various kinds to the hand and wrist soreness stress arthritis in the hand carpal tunnel etc Total duration of 40 minutes Combining different types of pulse square wave produces a generalized analgesic action on the area to be treated pulses at different frequencies stimulate the nerve fibers of different caliber favouring the inhibitory action at the spinal level Intensity adjusted from the perception threshold and the pain threshold without producing muscle contractions Location electrodes forming a square over the area to be treated as in Figure 1 TENS 11 Plantar stimulation This program is able to produce a relaxation effect and draining along the limb stimulated Ideal for people who suffer from heavy legs The duration is 40 minutes Intensity just above the threshold of per
20. ich mechanically hinder the movement articulate it also causes a thickening and stiffening of the joint capsule which together with the contraction of the muscles around the joint further contribute to the limitation of range of motion TENS is a treatment that soothes the pain caused by this disease but it is not a therapy practitioner Together with the TENS TENS 1 can stimulate the area to be treated with a low frequency current TENS 2 in order to cause a de contraction of the muscles son Number of Frequency Electrodes Pathology Program i treatment Treatment Dayily TENS1 f TENS 1 Up to pain up to 2 3 On the painful Arthrasi TENS 2 reduction times per day area TENS 2 daily Neck pain TENS 5 10 12 i 2 de Picture 25 Cervicogenic Once or twice o TENS 5 10 12 Picture 25 headache a day Picture 25 but with all Back pain TENS 6 10 12 Daily electrodes placed 10 cm lower Backache TENS 6 12 15 Daily Picture 27 Sciatic pain TENS 6 15 20 win co Picture 28 Picture 18 with O jo all electrodes Cruralgia TENS 6 15 20 nee or ewiee placed on the 5 a day E inside of the thigh IACER S r l 17 of 24 MNP152 Rev 03 03 07 15 I le MEDICAL DIVISION Epicondylitis TENS 15 15 20 a Picture 29 Hip pain TENS 1 10 20 a Picture 30 Knee Pain TENS 1 10 20 ur gt Re A Daily up to Ankle sprain TENS 3 5 7 2 3 m sa day Picture 32 Car
21. loser to any part of the device EN 61000 4 3 to 2 5GHz 2 5GHz including cables than the recommended separation distance calculated ftom the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 VP 150kHz to 80MHz d 1 2 VP 80 MHz to 800 MHz d 2 3 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer and d is the recommended separation distance in mettes m Field strangths from fixed RF transmitters are determined by an electromagnetic site survey should be less than the complicance level in each frequency rage Interference may occur in the vicinity of equipment marked with the following symbol 62 Recommended separation distances between portable and mobile communications equipment and the device The device is intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communication equipment Rated maximum Separation distance according to the frequency of the transmitter m power of the transmitter W 150kHz to 80MHz 80MHz to
22. m intensity is represented by the time when the musculature surrounding the treated area begins to contract beyond this limit the stimulation does not increase its effectiveness but only the sense of annoyance so it s good to pause before this threshold The number of treatments to achieve the initial benefits is between 15 and 20 daily continue in treatment until the symptoms have disappeared Duration of program 40 minutes Position of electrodes refer to the picture of the positions 27 and 28 TENS 7 Sprains Bruises After this type of injury the program develops its effectiveness with a pain inhibitory action at the local level producing three different pulses with selective action Intensity adjusted from the perception threshold and pain threshold Programme duration 30 minutes Number of treatments up to pain reduction on a daily basis even 2 3 times a day TENS 8 Vascularization Vascularizing produces an effect in the treated area The action vascularizing produces an increase in blood flow resulting in a positive effect on the removal of substances algogenic and a restoration of normal physiological conditions Do not place the electrodes in close proximity to areas prone to inflammation The frequency of application is suggested daily the number of applications is not defined the program can be used to reduce the pain itself The intensity of stimulation suggested should be between the perception threshold and t
23. n arrow to decrease the intensity MIO PERISTIM recognize 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 PERISTIM An acoustic signal advises the user when the treatment is completed Press the SET button to pause the treatment To restart the program press O OK button Turn off the device keeping pressed the O 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 MIO PERISTIM 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 MEM 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 e Press SET to confirm e Adjust frequency Hz pressing A increase and W decrease CH1 or CH2 buttons e Press SET to confirm e Adjust width impulse us pressing A increase and W decrease CH1 or CH2 buttons e 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 steppi
24. need a particular regular maintenance If you find any malfunctioning using MIO CARE PRO please follow these instructions e MIO PERISTIM 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 PERISTIM 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 PERISTIM 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 the manufacturer e MIO PERISTIM 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 PERISTIM 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
25. ng Decrease the intensity pressing Y buttons IACER S r l 10 of 24 MNP152 Rev 03 03 07 15 I TECH TENS and pelvic rehabilitation For TENS programs the intensity should be adjusted to a level between the thresholds of perception and pain The maximum limit is reached when the muscles surrounding the area treated begin to contract It is best to stay below that limit The electrodes should be positioned to form a square surrounding the painful area using Channel 1 and Channel 2 as shown in illustration 1 electrodes over the painful zone Keep 4cm minimum distance between Black electrodes Red WARNING Painful Ehanneld Channel 2 Create a square area with the area Regarding the use of probes for vaginal and anal stimulation follow these simple steps e After connecting the cables to the probe electro stimulation grease it lightly with suitable lubricants can be purchased at the pharmacy on the advice of your pharmacist doctor in order to facilitate the introduction into the vagina or anus e Lay back and eventually take the gynaecological position with a pillow under your lower back In any case the best position to take is the one that creates less discomfort and annoyance also in consideration of the fact that it must be maintained throughout the treatment time maximum 30 minutes Carefully insert the probe into the vagina or anus taking care to place it at least up to two golden rings before starting th
26. nts and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Electromagnetic immunity The device is inteded for use in the electromagnetic environment specified below The customer or the user of the device should assure that is used in suche environment Immunity test Test level EN Compliance level Electromagnetic environment 60601 1 2 guidance Electrostatic discharge 6kV contact 6kV contact Floors sholud be wood concrete ESD 8kV air 8kV air or ceramic tile If floor are EN 61000 4 2 covered with syntethic material the relative humidity should be at least 30 Mains power 3 A m 3 A m Mains power quality should be electromagnetic field at that of a typical commercial or EN 61000 4 8 hospital environment IACER S r l 23 of 24 MNP152 Rev 03 03 07 15 Q MEDICAL DIVISION Guidance and manufacturer s declaration electromagnetic immunity The device is inteded for use in the electromagnetic environment specified below The customer or the user of the device should assure that is used in suche environment Immunity test Test level EN Compliance level Electromagnetic environment 60601 1 2 guidance Conducted RF 3 Vrms 150kHz 3 Vrms 150kHz to Portable and mobile RF EN 61000 4 6 to 80MHz 80MHz communications equipment should be RF Radiata 3 Vrms 80MHz 3 Vrms 80MHz to used no c
27. pal Tunnel TENS 1 10 12 gir os Picture 33 Poon TENS 18 10 12 Daily Picture 24 TENS 1 Once or twice E Wryneck TENS 9 8 10 aday Picture 25 Periarthritis TENS 17 15 20 Daily Picture 26 Important In all of these programs the stimulation intensity to be adjusted between the p prog gt y J perception threshold of the pulse and the time when the impulse begins to cause discomfort With the exception of the periarthritis the muscles surrounding the treated p P 8 area should not shrink but only produce slight vibrations URO PROGRAMS Prg Phase 1 Total time 25 min Frequency 40 Hz Impulse width 180us contraction recovery 3 7 sec Total time 25 min Frequency 45 Hz Impulse width 180us contraction recovery 6 9 sec Total time 25 min Frequency 50 Hz Impulse width 180us contraction recovery 8 12 sec Total time 30 min U4 Frequency 8 Hz Impulse width 180us Total time 25 min U5 Frequency 10 Hz Impulse width 180us Total time 25 min Frequency 12 Hz Ul U2 U6 IACER S r l 18 of 24 MNP152 Rev 03 03 07 15 Impulse width 180us Total time 25 min Frequency 20 Hz Impulse width 180us contraction recovery 3 7 sec Total time 25 min Frequency 22 Hz Impulse width 180us contraction recovery 6 9 sec Total time 25 min Frequency 25 Hz Impulse width 180us contraction recovery 8 12 sec U7 U8 U9 URO 1 2 3 Stress urinary
28. the electrodes all moved toward the inside of the arm with a rotation of about 90 TENS 14 Periarthritis The humeral periarthritis is an inflammatory disease that affects the tissues surrounding the joint fibrous type tendons connective tissue and serous bags These appear altered and fragmented and may calcify It is a disease which if left untreated it can become very disabling For this reason after running a cycle of 15 20 applications once a day to reduce the pain you may want to start a cycle of rehabilitation consists of exercises specific consulting your doctor IACER S r l 16 of 24 MNP152 Rev 03 03 07 15 MEDICAL DIVISION The program is composed of various steps including the steps of TENS and muscle stimulation in order to improve the tone of the muscles surrounding the joint Program duration 41 minutes adjusted intensity above the threshold of perception with small muscle contractions at the end of the program when 10 minutes ARTHROSIS Arthrosis time and causing a progressive degeneration of the joints joint is formed by two or more heads of bone cartilage ligaments synovial membrane articular capsule tendons and muscles thus causing a limitation of increasing joint mobility The main action of osteoarthritis is to cause a progressive deterioration of cartilage which is not able to reform and bone with secondary deformation of the same and manufacture of growths called osteophyte wh
29. 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 L A 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 MNP152 Rev 03 03 07 15 a aC MEDICAL DIVISION Warranty Make reference to the national laws for any warranty conditions by contacting the national distributor or directly the manufacturer LACER MIO PERISTIM All rights reserved MIO PERISTIM and menen sion logos are owned by LA C E R S r l and are registered EMC Tables Electromagnetic emission Emission test Compliance Electromagnetic environment guidance RF emissions Cispr 11 Group 1 The device 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 The device is suitable for use in all establishments including domestic establishme
30. ttery once in a month even if the device is not used e 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 Carriage precautions MIO PERISTIM is a portable device so it does not need any particular carriage precautions However we recommend to put away MIO CARE PRO and its accessories in their own bag after every treatment Storage precautions MIO PERISTIM is protected till following environmental conditions In operation Temperature from 5 to 40 C Relative humidity from 30 to 75 Pressure from 700 to 1060 hPa Inside of the packaging IACER S r l 21 of 24 MNP152 Rev 03 03 07 15 Temperature from 5 to 55 C relative humidity from 10 to 90 Pressure from 700 to 1060 hPa Information for disposal The equipment is subjected to WEEE regulations see the symbol mm 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 CARE PRO does not
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