WEPERE MIO-CARE FITNESS User manual

USER MANUAL
The wave that makes your sport electric.

3 USERMANUAL
Electrotherapy
MIO-CARE
TENS,BEAUTY,FITNESS
USERMANUAL

5 USERMANUAL
Technicalinformation
Manufacturer 7
Declarationof conformity 7
Classification 8
Purposeandscope 8
Technicalfeatures 9
Deviceandcommands description 10
Labelling 12
Packagecontent 13
Introductiontothe technology 14
Contraindications 15
Sideeffects 15
Warnings 15
Patientpreparation 18
Operatinginstructions 18
TENSprograms 19
Treatment programs for TENStherapy 29
Beautyprograms 30
Treatment programs for musclesfirmingupand lipolysis 36
FITNESSprograms 37
Treatment programs for musclestrength 44
Self-adhesive electrodes 44
Maintenance 45
Troubleshooting 46
Battery charging 47
Battery substitution 48
Disposal 48
Warranty 49
Support 50
Sparepart 50
Electromagneticinterferencesandelectromagneticcompatibilitytables 51

USERMANUAL 6
WARNING: MIO-CARE IS A MEDICAL DEVICE.
Consultyourdoctor beforeusingMIO-CARE, if you suffer fromhealth problems.
Readcarefullythe user and the electrode positioning manuals beforeusingMIO-CARE.
Readcarefullycontraindicationsandwarnings.

7 USERMANUAL
Manufacturer
I.A.C.E.R.S.r.l.
viaEnzoFerrari 2 •30037Scorzè(VE) -Italy
Tel.[phone]•Fax[phone]
IACERS.r.l. isanItalian manufacturerofmedicaldevices (certified CEn°0068/QCO-DM/234-2020
from theNotified Bodyn° 0068 MTIC InterCert S.r.l.).
Declarationofconformity
I.A.C.E.R. S.r.l
viaEnzoFerrari 2 -30037Scorzè(VE) -Italy
herewith declares underitsown responsibility,thatthe product
MIO-CARETENS
MIO-CAREFITNESS
MIO-CAREBEAUTY
UMDNSCode:13762
hasbeendesigned and manufacturedaccordingto theEuropeanMedicalDevice Directive 93/4/
EEC(transposedin Italybythe D.Lgs.46/97),asmodifiedby theDirective2007/47/EC (D.L-
gs.37/2010) and furthermodifications/integrations.
Theproduct has beenassignedto class IIa,accordingtoAnnex IX, rule 9 ofthe Directive 93/42/
EEC(andfurther modifications/integrations)and bears themark
0068
Complianceofthe concerned productwith theDirective 93/42/EEC hasbeenassessedand
certified by the NotifiedBody:
0068–MTICInterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123, Italia
Certified number: 0068/QCO-DM/234-2020
followingthe certification procedureaccordingto Annex II
(excludingpoint 4)ofthe Directive93/42/EEC.
Scorzè, 31/01/2022 MASSIMOMARCON
Place,date LegalRepresentative

USERMANUAL 8
Classification
TheMIO-CAREhas thefollowingclassification:
• classIIa(Directive93/42/EEC,Annex IX, rule 9,10and furtheramendments);
• classIIwithBFtypeappliedpart(classification EN 60601-1);
• equipmentprotection levelIP22against liquid and dustpenetration;
• equipmentandaccessoriesnotsubject tosterilization;
• equipment unsuitable for use in presence of a flammable anesthetic mixture containing air,
oxygen and nitrousoxide;
• equipmentsuitableforcontinuous operation;
• equipmentunsuitableforoutdoors use.
Purpose and scope
Clinicalintendeduse:Therapeutic
Environmentalintendeduse:Ambulatory andhome
The MIO-CARE electronic stimulator is a medical device specifically intended for domestic use
and is targeted to adults, who acquired the specific knowledge to use the device by reading the
presentmanual.Itisalsointendedtobeusedbytherapist,bypersonaltrainerinacenterorpriva-
teclinicandby healthprofessionalinaestheticcenter.
MIO-CAREisusedtoapplyelectricalmicroimpulseswhichcreateenergy;thisenergy, modulated
withdifferentparametersspecificfordifferentimpulses,cangivethepatientmanybenefitsfrom
pain relief to muscles relaxation, from muscles strengthening to drainage, from isotonic exerci-
sestohematomas’ treatment, tothe treatmentof the imperfectionsusingthe beautyprograms.
The patient population intended for electrotherapy treatment using the MIO-CARE device inclu-
des patients of both genders, men and women, of age (unless otherwise indicated by medical
doctors). For furtherdetails, please refertothe Contraindications section.
The CE0068 mark is only for the medical programs (see the following paragraphs related to the
detaileddescriptionofthe programs).

9 USERMANUAL
Technicalfeatures
Characteristics Specifications
Powersupply Rechargeablebatteries AAANi-MH 4.8V800mAh
Recharger powersupplyline AC100-240V,50/60Hz, output DC
6.0V,300mAh max*
Isolation(EN60601-1) II
Appliedpart (EN60601-1) BF
Protectionlevel IP22
Appliedpart tothepatient Electrodes
Dimensions
(lengthxheight xdepth) 136x61x21mm
Weightmainbody 220grincluding batteries
Layout ABS
Programs’number
55total, divided into:
• N.20 TENS
• N.15 BEAUTY
• N.20FITNESS
Numberoutputchannel 2 independentand galvanically isolated
Functioning Continuous
Outputvoltage Setable,max outputvoltage 92Vwith500Ohm ofload
Impulse Rectangular, biphasicand compensated
Frequency From1 to150Hz
Impulse’s width From 50to300μs
Therapy Timedependingonthe program
Display ReflectiveandilluminatedLCDdisplay
Command ABSkeyboard with 7keys
Conditionsofuse
Environmental
temperature From+5° to+40°C
Relative humidity From30% to75%
Atmospheric pressure From700to1060hPa
Storage andtransportationconditions
Environmental
temperature From-10°to+55°C
Relative humidity From10% to90%
Atmospheric pressure From700to1060hPa
WARNING.thedevice hasanoutput current over10mA.
*Use onlythebatteryrechargergiven bythe manufacturer. Theuse ofotherrecharger couldseriou-
slycompromisethe security andsafety both ofthepatientand ofthedevice.

USERMANUAL 10
1. CH1output
2. CH2 output
3. Batterycharger connector
4. Display
5. IncreaseintensityCH1
6. Decreaseintensity CH1
7. Next program(onlyforTENS model), program groupselection(BEAUTY and FITNESSmodels)
8. IncreaseintensityCH2
9. Decreaseintensity CH2
10.Previous program (onlyforTENSmodel), program group selection
(BEAUTY and FITNESS models)
11. SwitchdeviceON/OFForstopthe program
12.Beltclip
13.Battery compartment
Deviceandcommandsdescription

11 USERMANUAL
1. PRGgroup selection
2. Selectedprogram
3. CH1intensity
4. Activechannels
5. Lowbattery status
6. Nextphase
7. CH2intensity
8. Countdowntimer
9. Devicerunning
PROGRAM Indicatesthe program chosen (2).
Therotor,changingevery second,indicatesthat thedeviceis running(9).
TIME Indicatesthe amount of timeleftbeforethe program ends(8).
Warnsthe user to increasethe intensity by1or 2 units(usingthe key) (6).
Indicates which of the 2 channels is active: the left arrow indicates that CH1 is
active,therightarrowindicatesthatCH2isactive,botharrowstogetherindicate
thatboth CH1andCH2 are active (4).
Indicatesthe intensity selected for channel 1(3).
Indicatesthe intensity selected for channel 2(7).
Indicateslowbattery(5).

USERMANUAL 12
Labelling
Symbol Description
Manufacturer’slogo.
0068 Product CE certificationreleasedbyNotified Body n°0068.
Appliedpart typeBFaccordingtoEN60601-1, 3rd edition.
Manufacturer
Manufacturing date (YYYY-MM)
Readinstructionsforuse
Theproduct must be disposed as “electronicwaste”,inaccordanceto
WEEEDirective on waste electrical and electronic equipment.
IP22 Medicaldeviceprotected againstthe penetrationofsolids(with a diameter
d≥12,5mm) and against the vertical drops when the device is kept at 15°
from its normal functioning position.
Limitsofrelative humidity (relativehumidity of thestorageenvironment,
onthepackage).
Temperature humidity (temperatureofthestorageenvironment, on the
package).

13 USERMANUAL
Packagecontent
TheMIO-CAREbox contains:
• N°1mainframe;
• N°2connectioncables,2 clips each, forthe transmissionofelectrical impulses;
• N°4splittingleads,2 clips each, fordoublingthe areacoveredbythe electrodes;
• N°1set of 4 pre-gelledelectrodes41x41mm;
• N°1set of 4 pre-gelledelectrodes40x80mm;
• N°1batterycharger;
• N° 1bagforthe transportation;
• N° 1usermanual;
• N°1user manual of theelectrodes’positions.

USERMANUAL 14
Introduction tothe technology
Electrostimulationconsists of thetransmission of electricmicro-impulses to thehumanbody.
Fields of application of electrostimulation are pain therapy, recovery of muscle trophism after
injury or a surgicaloperation, athleticpreparation and beautytreatments.
Specificelectric impulsesareused for everyone of theseapplications.
ThestimulationintensityisdisplayedontheMIO-CAREscreenforeachchannelinaprogressing
scalefrom 0 to50.
Once the initial intensity has been set, MIO-CARE will proceed until it reaches the end of the pro-
gramanddoes not require anyfurther action fromthe user.
Thetypes ofimpulsescan be classifiedasfollows:
1. TENS impulse: for TENS programs, the intensity should be adjusted to a level between the
thresholdsof perceptionandpain.Themaximumlimitis reached when themuscles surrounding
thetreatingareabegin to contract.Werecommendstayingbelowthat limit.
2. Lipolysis/drainageimpulse: the“pump”effectisproducedbysequentialtoniccontractions.
The intensity must be enough to produce these contractions: the greater the contraction is, the
greater the pump effect will be. But beware: there is no benefit to be gained from enduring in-
tensity high enough to cause pain. The first electrostimulation sessions should be carried out at
a low intensity to allow the organism to get used to new sensations. In this way intensity can be
increasedgradually and willnotbe traumatic.
3. Warming-up impulse: stimulation intensitymust beincreased graduallyto improveprogres-
sively the metabolism of the muscle concerned. A bit like a car: the engine needs warming-up
beforetaking it tofullspeed.
4. Toning,training,atrophycontractionimpulse:themuscletreated must visiblycontractdu-
ring a training impulse. The fact that the muscle tends to stiffen and increase in volume will be
visible. Intensity should be increased gradually (in the first contraction) to enable you to identify
the right level of stimulation comfort. Intensity can be increased up to the personal tolerance
threshold during the second training contraction; this operation is then repeated during each
contraction until the workload reaches the level of intensity recommended in the description of
the single programs. We recommend that you record the level of intensity reached in order to try
toimprovethe level ofstimulation andtherefore your performance.
5. Massage, winding down, active recovery impulse: intensity must be adjusted gradually to
massage the muscle treated. The level of intensity should be enough to obtain a comfortable
massage. There is no need to endure high intensity levels in this case as it is meant to be a mas-
sage,meaningthat intensity canbeincreased graduallywithout excesses.
6. Capillarizationimpulse:increasetheintensitygraduallytoproduceconstant,visiblestimula-
tionof thearea treated; amedium stimulationthreshold isrecommended, always below the pain
threshold.

15 USERMANUAL
Contraindications
The device must not be used in presence of cancerous injuries in the area to be treated. The sti-
mulation should not be applied to infected, swollen or inflamed areas and in case of rashes (ph-
lebitis,thrombophlebitis,etc.).
It is absolutely forbidden to use MIO-CARE if the patient suffers from severe arrythmia or has a
pacemaker, suffersfromepilepsy,heart-relatedpathologies,phlebitis inplace,thrombophlebitis,
in feverish state, anxiety or serious illnesses, abdominal or inguinal hernias or in case of severe
injuries in thearea to betreated (exceptincase of medical prescription).
Donotusethe deviceifthe sourceofthe pain isunknownornot diagnosed. Use the device ONLY
after having adiagnosis. In the event ofinjury, muscle stress orany otherhealth problem consult
yourdoctor before usingthe device andonly use itundermedical supervision.
Sideeffects
Nosignificantsideeffectsareknown.Insomecasesofparticularlysensitivepeople,skinredness
occursat the electrodes after treatment:the redness normally disappears few minutes aftertre-
atment. Ifthe redness persists,consulta doctor.
In some rare cases evening stimulation causes some difficulties in falling asleep. In this case,
suspendthe treatmentand consult a doctor.
Warnings
Treatment efficacy depends on the patients’ selection by qualified persons. The long-term
effects of a chronic stimulation are unknown. MIO-CARE has been designed and manufactu-
red to be operated exclusively with the internal, rechargeable batteries.
Itisrecommended:
• tocontrol positionandmeaningof all thelabelson theequipment;
• nottodamagetheconnectioncablestotheelectrodesandtoavoidwindingthecablesaround
thedevice;
• to avoid the use of the device by persons who did not read carefully this manual. Keep the de-
viceawayfrom children,itcontainssmall pieces thatcould be swallowed;
• nottowearmetal objectsduringtreatment;
• tousetheelectrodesoncleananddryskin.Whenusingtheelectrodes,followtheinstructions
given in the manual and on the package of the electrodes. Use only single-patient electrodes,
supplied exclusively by the manufacturer, and take care to avoid the exchange of electrodes
between different users. MIO-CARE has been tested and guaranteed for the use only with the
electrodes suppliedbythe manufacturer;

USERMANUAL 16
• to use ONLY accessories supplied by device manufacturer. Only use battery chargers sup-
plied 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 theusertoriskssuchas short circuitsandfire.
Itisforbidden:
• tousethedeviceinthepresenceofpatientmonitoringequipment,ofelectrosurgical(possible
bruises and burns) or shortwave or microwave therapy equipment or other equipment that
sends electrical impulses into the body and in general in combination to other medical devi-
ces,sinceit could cause problemstothe stimulator;
• to use the device close to flammable substances/gas/explosives, in environments with high
concentrations of oxygen, with aerosol-therapy devices or in wet environments (use of the
deviceisprohibitedin bathroomorshower areas or whileshowering/bathing);
• tousethedevicebypersonsknowntobeunsound-minded,orsufferingfromsensibilitydisor-
ders,permanentlyortemporarilydisabledunlessassistedbyqualifiedpersonnel(e.g.adoctor
ortherapist);bypersonsyoungerthan15yearsoldornotadequatelyeducatedaboutthedevi-
ceuseby an adult person;
• to use the device in presence of signs of deterioration of the device itself, cables and/or
electrodes: please contact the dealer or the manufacturer following the instructions given in
theparagraph Support.Control carefullythe integrity ofthe device beforeeachuse;
• to position the electrodes in such a way that the current crosses the heart area (e.g. a black
electrode on the chest and a red electrode on the shoulder blade); however, electrodes can
bepositioned along themuscular fasciaof the heart area, as used for pectoral strengthening.
Dangerofheart arrythmia;
• to position the electrodes close to the eyes; make sure that the current delivered does not
crosstheeyeball(oneelectrodediametricallyoppositetotheotherinrelationtotheeye);keep
adistanceofat least 3cmfrom theeyeball;
•to position the electrodes on the carotid sinuses (carotid) or genitals, in particular in pa-
tient with a well-known sensibility on reflection of the carotid 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 this stimulation
could cause important muscle spasms that can obstruct the airways, creating difficulty in
breathing and problems with the heart rhythm and blood pressure;
• tousepointedor sharpobjectsonthe device keyboard.

17 USERMANUAL
Warning:
• insufficientlysized electrode sections can cause skin reactionsor burns;
• donotuse damaged electrodes even ifthey well adhere tothe skin;
• besurethat theelectrodeswelladhere to theskin. Repeateduseof thesameelectrodescan
compromisethe safety ofthe stimulation,in factitcancause skinrednessthat canlastfor
manyhoursafter stimulation;
• payattention touseconnectioncableswithchildren/young people: strangulation danger;
• donotmixconnectioncablesupwithearphonesorotherdevicesanddonotconnectthecable
toother equipment;
• keep right distance between electrodes: the contact between electrodes could cause wrong
stimulations or irritations/burns;
• stimulation intensity and electrodes position should be suggested by the prescriber doctor;
• duringtreatmentwith round and 41x41 mm electrodes, current density maybe in excess of 2
mA/cm² foreachelectrode.In thesecases,takespecial care regarding anyskin redness.
The manufacturer considers himself responsible for the performances, reliability, safety and se-
curity ofthe device onlyif:
• anyaddition, modificationand/orrepairarecarried out by authorizedpersonnel;
• the environmental electrical installation to which MIO-CARE is connected is compliant to the
nationallaws;
• theinstructionsforuse contained in thismanual are strictly followed
Should any foreign materials penetrate the device contact the retailer or manufacturer
immediately. If dropped down, check that the housing is not cracked or damaged in any
way;ifso,contactthe retailer or manufacturer.
Should you notice any changes in the device’s performance during treatment, interrupt
thetreatmentimmediately and consultthe retailer or manufacturer.
If the stimulation is uncomfortable decrease intensity. If the problem persists consult a
doctor.
Somepatientscouldsufferfromskinirritationoroversensitivityduetostimulationorgel.
Ifthe problem persists,suspendthe stimulationand consult a doctor.
Consultadoctor beforeusingMIO-CARE withmetallic osteosynthesisdevices.
IFYOUHAVEANYDOUBTSREGARDINGTHEDEVICE USE CONSULT YOURDOCTOR.

USERMANUAL 18
Patientpreparation
BeforeusingMIO-CARE cleantheskin oftheareatobetreated;withthecabledisconnectedfrom
MIO-CARE, connect the electrostimulation cable jacks to the self-adhesive electrodes; position
the self-adhesive electrodes on the skin (see photos of electrode positions in the Positions ma-
nual);connecttheimpulsetransmissioncablestotherelativejacks(Channel1and/orChannel2),
thenturnMIO-CAREon.
Splitting leads use: please use splitting leads if you want to double electrodes number for each
channel. Connect the splitting cable jacks to the self-adhesive electrodes, with the cable discon-
nected from MIO-CARE; position the self-adhesive electrodes on the skin (see photos of electrode
positions in the Positions manual); connect the splitting leads cables to the impulse transmission
cablesthatareconnectedtotherelativejacks(Channel1and/orChannel2),thenturnMIO-CAREon.
MakesurethatMIO-CAREisswitchedoffbefore disconnecting the electrodes at the end
of the treatment.
Deviceuse
Operatinginstructions
Itisrecommended reading theentire user manualbeforeusing.
1. Turn MIO-CAREonusingthe ON/OFF button.
2. The displayshows thenumberof the programs onthe upperside, theselected programnum-
beronthe middle-left side and onthe rightthe programtime:
3. Select the program group using the MODE button (no selection is necessary for the
TENSmodel).
4. Selectthe program usingthe PRG key(fortheTENSmodelselect theprogramusingthePRG+
andPRG- keys).
5. To start the session press skey of the selected channel CH1 or CH2 and increase the output
current intensity till the personal tolerance level is reached (stimulation comfort).
icon starts blinking on the display. The ▼key can be used to reduce the power if the intensity
istoohigh.

19 USERMANUAL
6. Stimulation intensity is showedonthe displayina scale progressing from 0 to50.
7. At the end of the program (always pre-set by the manufacturer), the stimulator will return to
theinitial screenofthe selectedprogram setting the intensityto zero.
8. ToturnMIO-CARE offpressON/OFF key.
Stop program command: pressingthe ON/OFF button once whilst the program is running inter-
rupts theprogram.
WARNING! MIO-CARE will enter into sleeping mode, if no key is press for longer than 2
minutestopreserve battery.
TENSprograms
WARNING! It must be remembered that an electronic stimulator is a very effective anal-
gesicinstrumentandthat paincanindicatevarioustypes ofmedicalconditions!
The programs described in this paragraph are analgesic. You are advised to read the ENTIRE ma-
nualcarefully before using MIO-CARE.
Moreover, remember that pain is a SIGN: consult a doctor to identify the medical condition
beforeusing MIO-CARE!
TENS, an acronym standing for Transcutaneous Electrical Nerve Stimulation, is a therapeutic te-
chniquemainlyusedforanalgesicpurposestocountertheeffects(usuallypain)ofawidevariety
of medical conditions. For this purpose, it finds application in treating everyday ailments trou-
bling mankind: neck pain, arthrosis, myalgia, neuritis, back pain, periarthritis, heaviness in legs,
muscleweakness, justtomention afew.
On an academic level, TENS can be divided into various categories according to the mechanism
usedtoreduce thepain.Themain typesare: conventionalTENS(orfastanalgesic),trainingTENS
(ordelayedanalgesic),whichissimilartotheeffectoftheelectroacupuncture,TENSatmaximum
valueswith antidromicactionandconsequentlyanimmediate local anaestheticeffect.
The rehabilitative action of TENS is represented by its power to reduce pain thereby restoring
physiologicalconditions;mostofthetimethisallowsthepatienttoregainnormalmotorfunction.
Considerapatientsufferingfromirritatingperiarthritis;thepatientusuallyresortstouseanalge-
sics or learns to live with the pain, which often makes even the simplest movements impossible.
Immobility reduces metabolic activity making it impossible to eliminate allogenic substances.
So, a vicious circle begins. In addition to relieving pain, TENS causes induce muscle stimulation

USERMANUAL 20
increasing metabolic activity and blood flow and improving tissue oxygenation with an intake of
nutritional substances. Therefore, the positive effect can be amplified by combining TENS with
musclestimulation ofthe area concerned.
Electrodes’positioningandintensitylevels
Theelectrodes havetobepositioned to formasquare over thepainfulzonebyusingthe channel
1and2 as shownabovein Figure 1(redor black up ordown arenotimportant for thetherapy pur-
poses,followthe indicationsinthe Positionsmanual).
IMPORTANT
Create a square area with the electrodes
over the painful zone. Keep 4cm minimum
distancebetweenthe electrodes.
Figure1–Electrodes’positioning.
The intensity should be adjusted to a level between the thresholds of perception and pain: the
maximumintensitylevelis themomentinwhichthe musclessurrounding thetreated area begin
tocontract;overthislimitthestimulationdoesnotbecomemoreeffective,justmoreirritating,so
itisbest to stop beforethat point.