DATA SHEETRELIFE

MOD. ReLIfe ST_RELIFE_engED. 1/2017

Medical Engineering

Winform ɘЯLife is a device that allows the biosti-mulation and the nourishing of the scalp, taking care and balancing the condition of the hair, eliminating dandruff and dryness, giving them gleam and making them stronger and more voluminous.

The system is able to control the energy absorbed by the various anatomical tissues and quantify it, which is fundamental in order to record the application.

The revolutionary hanpiece combines TRANSDER-MAL DELIVERY and LLLT.

Transdermal Delivery ModeCombined action of TECAR and Transdermal Delive-ry.It allows the operator to use electroporation with high density of absorption, which is indispensable for pathologies both in acute and chronic phase.It emits monopolar pulses at 480 KHz and 10 Hz, allowing the operator to choose the depth of the tis-sues to be crossed up to the desired spot. Specific hydrosoluble active ingredients are used.

Why LLLT?It is a laser technique developed in the United States (approved by FDA) called “Low-Level Laser Therapy” because it makes use of low intensity laser beams, able of bringing significant benefits to the hair health.

During the treatment, the laser penetrates the scalp and, associated with the transdermal vehiculation of active ingredients specially designed by Winform laboratories, it intervenes on the activity of the hair follicles by stimulating the production of healthy and stronger hair.

ɘЯLifeshows on the display

the temperature and

the amount of water

of the treated area.

Data detection system, through the evaluative handpiece W200, allows the operator to control the treatment by photographing the area to be treated before, during and after the treatment.

The the evaluative handpiece also allows to measure the amount of water in the tissues, degrees Celsius and microscope up to 200X magnification for the di-splay.

SIVSEA system displays all the pa-rameters of emission and respon-se, monitoring in an effective and immediate way the propagation of energy through the body, correcting the excessive thermal effects.(SIVSEA PATENT)

SCE system allows to view and con-figure the real and nominal energy of the body, necessary to calculate the correct energy output.SCE PATENT

EvaluativeMode

Contraindications:Do not use the device on:

• Pregnant women• Patients with pacemaker• Skin lesions not cicatrized yet• Varices • Patients with metal, electric or auditory prosthesis• Anesthetized areas • Patients incapable of informing the therapist about any

conditions of pain • Patients with tactile sensibility and thermal sense

disorders• Neoplastic areas• Avoid the preson to contac the grounded conductive parts

that cause unwanted trajectories to the radiofrequency currents.

• It is important to prevent patients from coming into contact with the conductive parts, placed on the ground, that cause undesirable trajectories of radio frequency currents. In hypotensive patients, as the treatment gets longer, the arterial blood pressure may decrease. Reduce the treatment duration and extend the intervals between sessions.

Warning: operating in close proximity (1 metre) from shortwave or microwave treatment devices may deter-mine instability in the output.

Warning: the interference produced by the device may affect the operation of other electric devices.

Warning: any device failure may lead to an increase in power.

Warning: the device should not be used near or placed on other devices. However If this setting is necessary, the de-vice should be monitored in order to check the functioning of the normal configuration in which it is used.

Warning: the use of accessories, transducers and cables different from those specified, except those sold by the manufacturer, may cause an increase in emissions and a decrease in the device immunity.

The user’s manual reminds that the use of an electronic device prescinds from the observance of some basic sa-fety rules• Read thoroughly the instructions before using ReLIfe. • Make sure that the device is connected to a grounding

system.• This device is used only for the intended use.• Keep the device out of reach of children or of not allowed

persons.• Keep the device out of any heat sources.• If the device falls into water, avoid using it and call for a

technical intervention. • At the end of the treatment, disconnect the power supply

cables from the socket. • Do not open the device.• Do not turn on the device before connecting the cables

and the hand pieces.

• Before selecting the delivery mode (cap. or res.), make sure that the power regulator (knob) is on zero.

• Do not replace cables and electrodes when the device is operating.

• Before applying the electrodes on patient’s skin, turn the power on zero.

• Use only original WinForm accessories. • Regularly check the condition of the accessories• The device should be checked out at least once a year

Intended use and classification :

ReLIfe is an aesthetic equipment compliant with Legislative Decree 12.05.2011, intended to be used by qualified person-nel for the application of transdermal delivery and LLLT tre-atment in aesthetics.

Risk analysis:The risk analysis has been carried out during the design sta-ge of the device in compliance with the rule CEI UNI ES ISO 14971:2009, in order to minimize and make acceptable the risks linked to the use of the device and identified during the analysis itself. During the analysis, both the known and the foreseeable risks to which the operator, the patient and the environment may be subjected to in normal conditions or du-ring the first fault were taken into consideration together with the type of use of the device.

Quality System:See the Quality Manual and the procedures adopted in or-der to ensure the ability to supply regularly medical devices in compliance with the present technical file and the applicable regulations. The Quality System adopted is compliant with the rule UNI EN ISO 9001:2008 and ISO 13485:2012.

The production management procedures involved in the ma-nufacturing of this device are listed here below:

• P7.3-1 Planning management • P7.5-1 Production management and technical assistance • P7.6-1 Resources management • P8.0-2 Nonconforming management• P8.0-3 Corrective and correction action management • P9.0 Risk management • P9.1 Placing on the market• IO_RIN Traceability • IP_AC901 Inspection and assembly

Mode

Energy in Joule per cm2

TransdermalDelivery Mode

SCE

SIVSEA

LLLT

W200 handpiece

Manual

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✔Hair handpiecetransdermal delivery + LLLT

TECHNICAL SPECIFICATIONS

Power supply 230V a.c. 50Hz 180W 2A

Insulation Class CLASS I device

Device protection N° 3 fuses T2A 250VN° 1 fuse T1A N° 1 fuse T3,15A

Output Radiofrequency + LLLT

Display TFT 10.2”

Controls Backlit Rotative Digital ENCODER

Dimensions mm 350x250x280 (h)

Weight 10 Kg (only the device)

Number of Outputs 1

Electrical safety classification Class I

Working conditions 10°C- 35°C ; inferior 90%RHPressure: 500 - 1060 hPa

Storage conditions 10°C- 35°C ; inferior 90%RHPressure: 500 - 1060 hPa

Winform Medical Engineering S.r.l.30027 San Donà di Piave (VE) - Italy - Via Garda, 6 T. +39 0421 222026 F. +39 0421 225314info@winformweb.it

www.winformweb.it