I-Tech WEPERE RESTART Manual de usuario

USER MANUAL
Recover faster, anytime anywhere


3 USERMANUAL
Technical information
Manufacturer 4
Declarationofconformity 4
Classifications 5
Intendedpurposeandscopeofuse 5
Technicalspecifications 6
Devicedescription and controls 7
Labelling 8
Packcontents 10
How To Use
Introductiontothetechnology 10
Contraindications 11
Warnings 12
Deviceuse 12
Treatments 14
Looking after the device
Maintenance 14
Troubleshooting 15
Chargingthebattery 16
DisposalInformation 16
Warranty 17
Support 18
Spareparts 18
Interferenceandelectromagnetic compatibility tables 22

USERMANUAL 4
Manufacturer
I.A.C.E.R.S.r.l.
viaEnzoFerrari 2 •30037Scorzè(VE) -Italy
Tel.041.5401356•Fax041.5402684
Declarationofconformity
Themanufacter I.A.C.E.R.S.r.l
viaEnzoFerrari 2 -30037Scorzè(VE) -Italy
declaresunderitsownresponsibilitythattheproduct
RESTART
Isconformtothedispositionsoftheelectromagnetic compatibility Directive 2014/30/UE
oftheEuropeanParliamentandoftheCouncilofthe26thFebruary 2014,tothecurrent
TECHNICALSTANDARDon ELECTROMAGNETICCOMPATIBILITY EN 60601-1-22015
andthefollowingrules applied:
EN60601-12006 +A12013,EN60601-1-22015,IEC60601-2-52009,EN60601-1-62010+A12015,
EN60601-1-112015,ENISO 14971:2012,ISO10993-1:2009,ISO10993-5:2009,ISO10993-10:2010,
EN62366:2015.
Scorzè, 31/01/2022 MASSIMO MARCON
Place,date LegalRepresentative

5 USERMANUAL
Classifications
TheRESTARTdeviceassumes the following classifications:
• classIIwithtype BFappliedpart (Classif.EN 60601-1);
• device with IP22 protection degree against the penetration of solids and liquids into the ma-
chinebody.IPX7 protection degree for the treatmenthead.DEVICE NOTSUITABLEFORUSEIN
IMMERSION.
• equipmentandaccessoriesnotsubjecttosterilisation;
• devicenotsuitableforuseinthepresenceofaflammableanaestheticmixturewithairorwith
oxygen or with nitrous oxide;
• deviceintendedforcontinuousoperation;
• devicenotsuitablefor externaluse.
Intendedpurposeand scope ofuse
The RESTART device for ultrasound treatment is ideal for all muscle, tendon and ligament treat-
mentsincluding:
• Musclecontracture;
• Tendoncool-down;
• Relaxingmassage;
• Tissueoxygenation;
• Pre-competition preparation;
• Post-workoutrecovery;
• Tissuerecovery;
• Musclerelaxation.
Itisalsorecommendedusingthedevicefor the following aesthetictreatments:
• Cellulite;
• Drainingmassage;
• Microlifting.
Theuserofthedevicecan be either the useroraprofessionaloperator.

MANUALEDIUTILIZZO 6
Technicalspecifications
Feature Specification
PowerSupply IN:100-240V~,50/60Hz, 0.6-0.2A
OUT:15V 1.2A
Battery Ni-MH AAA850mAh 4.8V
Externaldimensions
(LengthxWidth xHeight) 204x 63x 58mm
Ingressprotection ratingIP IP22 machinebody
IPX7head
Insulation(EN60601-1) II
Appliedparts (EN60601-1) BF
Partapplied tothe user Aluminiumhead ofthedevice
Operation Continuous
Waveform Pulsed, continuous
Carrierfrequencyof use 1MHz± 10%
Modulationfrequency 100Hz±10%
Dutycycle 5%, 50%,100% (mainspowered)
5%,50%, 100%(batterypowered)
Power Canbe setin 3stepsL (low)- M(medium)-H(high)
Maximumpower density 1.6W/cm(mains powered)
0.8W/cm(batterypowered)
Maximumoutputpower 6.4W(mainspowered)
3.2W(battery powered)
RBN(max) 5.0
Headsurface 5 cm
Actual radiantarea 4cm ±20%
Beamtype Collimated
Headmaterial Aluminium
Treatmenttime 5,10,15 minutes
Usageconditions
Ambienttemperature From +5to+40°C.
Relative humidity From 15to93%
Atmospheric pressure 700-1060hPa
Transport andstorageconditions
Ambienttemperature From +5to+40°C.
Relative humidity From 15to93%
Atmospheric pressure 700-1060hPa
Usefullife ofthe deviceand itsaccessories: 3years.

7 USERMANUAL
Devicedescriptionandcontrols
1 Treatmenttimeindicator
2 Timebutton
3 Poweradjustmentbutton
4 Treatmentpowerindicator
5 Battery indicator
6 DeviceON/OFFbutton
7 Emitting head
8 Powersupplyconnector

USERMANUAL 8
Labelling
IPX7: for the device head only
I.A.C.E.R. Srl, via Enzo Ferrari 2
30037 Scorzè (VE) - Italy
Model: Restart
Power supply
In: 100-240V~, 50/60 Hz, 0.6-0.2 A
Out: 15V 1.2A
Battery: Ni-MH AAA850mAh 4.8 V
Ultrasound
Carrier frequency of use: 1MHz ± 10%%
Duty cicle:
5%, 50%, 100% (mains powered)
5%, 50%, 100% (battery powered)
Maximum output power:
6.4W (mains powered)
3.2W (batter powered)
RBN (max): 5,0
Actual radiant area: 4 cm² ± 20%
Wave form: pulsed, continous
Beam type: collimated
Modulation frequency: 100Hz ± 10%
Pulse duration: 0.5ms, 5ms
XXXXXX XXXX-XX
SN

9 USERMANUAL
Gel labelling
Followthe“instructions for use”
WEEEDirective
TypeBFappliedpart
ClassIIdevice
Incompliancewith Directive2014/30/UE
SN Serial number
Allowedtemperatures(storagetemperatures,onpackaging)
Relative humidity (storagerelative humidity,onpackaging)
Dateofmanufacture(YYYY-MM)
Powersupply
Warning,seethedocumentsaccompanyingthe product
IP22 Deviceprotected against the penetrationofsolids(with diameter
d≥12.5mm) and against the fall of vertical drops of water when the device
isheldat15°from the normaloperatingposition.
Expiry date
xxxx-xx
Shanghai International Holding Corp.
GmbH (Europe) Eiffestraße 80,
20537 Hamburg Germany
Shenzhen Dongdixin Technology Co., Ltd.
Floor 1-2, No.3 Building, Fanshen Xusheng
Industrial Estate Xilixiaobaimang 518108
Nanshan District, Shenzhen P. R. China
2 Anni a confezione integra /
2 years sealed condition

USERMANUAL 10
Packcontents
TheRESTARTpackcontains:
•1RESTARTdevice;
•1medicalpower supply;
•1batterycharger;
•1gelfor ultrasound;
•1carry bag;
•1usermanual.
Introduction tothetechnology
Ultrasoundtreatmentrepresentsamethodthatisbasedonthetransferofenergyintothetissues
whichresultsinthermal and non-thermal biological effects.
This treatment is based on the contact between the head of the device and the tissues being
treated.Theoptimalcouplingof these twosurfacesisensured bytheuseofawater-basedultra-
sound gel. Through the contact described the transmission of general mechanical waves from
the piezoelectric present inside the head of the device takes place. In order for there to be maxi-
mumtransmissionofenergyfromonemediumtoanother,theimpedanceofthetwomustbethe
same.Obviouslyinthecaseofthehumanbody, suchconditionhardlyoccurs.
Thegreatertheimpedancedifferencebetweenthetwomedia,thegreaterthereflectionandcon-
sequently the smaller the amountofenergy that will betransferred.Theimpedancedifferenceis
greatestwithaluminium-airinterface,whichisthefirstthatultrasoundwaveswouldhavetoover-
cometoreachthebody.Toreducethisdifference,acouplingsubstancemustbeused.Ifthereisa
smallamountofairbetweenthetransducerandtheskin,theproportionofultrasoundwavesthat
wouldbereflectedwouldreach99.998%,i.e.therewouldbe no transmission.
In addition to the phenomenon of reflection, if the wave does not hit the separation surface
between the media at 90°, refraction occurs. In practice, the direction of the ultrasound beam
through the second medium will be angled. The critical angle for ultrasound waves at the skin
surface appears to be 15°.If the device head is oriented at a 15° angle to the surface, most of the
beam will propagate through the epidermal tissues parallel to the skin rather than perpendicular
tothetissues.
The absorption of the energy released by the ultrasound waves follows an exponential trend, in
fact muchmoreenergyisabsorbedinsuperficialtissuesratherthanindeepones.
Precisely due to the trend of absorption, theoretically there is no point where all the energy is absor-
bed,butthereiscertainlyapointwheretheselevelsarenotsufficienttoproduceatherapeuticeffect.
Generally tissues with the highest protein content will absorb more, unlike tissues with high water
andlowproteincontent,whichwillabsorbaminimalamountofenergy(bloodandfat,forexample).
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