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safyre

- Manual de usuario/User manual/Manuel de l’utilisateur

MKT-07-M1/20160623/MAN00159

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Patients undergoing decogulation treatment

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In the first 48 h. of post-surgery for certain pathologies

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Bearers of metallic prostheses

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Patients with malign neoplasy

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Persons who are not temperature sensitive

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Active infectious processes



Persons who suffer from uncompensated arthropathies

Secondary effects

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Redness on the area treated



Feeling of high heat in the area treated for 30 minutes after the treatment

Содержание safyre

Страница 1: ...User manual Facial rejuvenation and body contouring in a single device ...

Страница 2: ...sportation Recommendations for the storage and handling of the product in order to avoid damage Initial verification Considerations to receive the device and list of components and accessories safyre General description Overview of the various safyre subsystems Installation Explains the electrical requirements space and environmental required for installation of safyre device Operation Explains ho...

Страница 3: ...ltage drops or surges WARNING Avoid connecting the safyre to the same electric line to which a sensitive apparatus is connected There are high currents inside the equipment that may be dangerous so no housing panel must be removed other than by personnel authorized by the manufacturer The safyre must never be left unattended when switched on The dispositive protection device is a timed fuse with c...

Страница 4: ...urity reasons before cleaning the device disconnect the power cable from the outlet 4 Access to the internal parts of the device should be performed by authorized service personnel For reparations or other information you should contact High Technology Products S L 5 For a correct usage of the handpiece make sure to handle it carefully avoiding accidental impacts that could damage it or reduce its...

Страница 5: ...therwise this could cause damage to the appliance or to people If there are any specific questions please contact our Technical Support at High Technology Products S L 20 You must only use glycerin or products and fluids specified by the manufacturer otherwise the warranty will be void Other safety requirements IMPORTANT For any questions on health status pregnancy lactation etc both the person wh...

Страница 6: ...nformation OFF Energy Present at the unit switch Indicates that the device is off and no power is being consumed Symbol IEC 60417 5134 Information Electromagnetic Interference Present in the supporting documents according to the requirements of the harmonized standard IEC60601 1 2 2007 Electromagnetic interference may occur if the device is placed nearby some device marked with this symbol Symbol ...

Страница 7: ...al obligations of the European Community directives are applicable Present on the main label of the device at the bottom rear Technical general warnings External Labeling of the Device Information Label present in the rear of the unit next to the power connector in accordance with the requirements of IEC 60601 1 harmonized standard for the basic safety of medical electrical device Symbols for sani...

Страница 8: ...namiento Storage Temperatura Temperature 2ºC 50ºC Humedad Humidity Sin condensación Non condensing 90 Outer packaging labeling of the Device Information Label present in the outer packaging of the device in compliance with the applicable requirements of the harmonized standard IEC60601 1 for operating conditions ...

Страница 9: ...y If you attempt to transport the equipment without adequate care the personnel may suffer harm Place the equipment away from sources of heat Keeps enough space around the device to guarantee its correct ventilation above all making sure never to obstruct the ventilation grilles of any of the panels of the device It is recommended that a minimum of 40cm separation between the back of the unit and ...

Страница 10: ...the manufacturer has taken the utmost care in packaging this might not be sufficient to guarantee that the merchandise has not suffered damage You should check The material received matches the list of components and accessories herein The outer packaging conditions of humidity external damage or any abnormalities That each of the components and accessories are in good condition Keep the original ...

Страница 11: ...safyre device 1 SD electrode holder body 1 Multipolar applicator body 2x2 1 Multipolar applicator body 3x3 1 Monopole applicator body 70 1 Monopole applicator facial 35 1 Massager 1 SD electrode holder facial 1 Passive plate 1 Massager accessory Glycerin dermic gel RF 1 Pedal 1 Guarantee certificate User and packaging manuals English and Castellan protocols 2 Display safyre 1 Conformity declaratio...

Страница 12: ...and a series of radio frequency heads with extractable accessories and mechanical massage safyre also includes accessories for patient safety during the treatment The following is a description of the main components of the device TFT Touch screen RF accessory connector Passive plate connector Mechanical massage accessory connector Pedal Accessory cradle Power switch I O Mains cord socket Air vent...

Страница 13: ... pay special attention to the internal electrical connection both the accessories as well as the base in case remains of gel or liquids are observed during handling Radio frequency body head RF body electrode holder Base of the body radio frequency head that allows manual connection disconnection of the different body accessories easily and comfortably Connector head Type of connection that allows...

Страница 14: ... 6 pin multipolar accessory so the radio frequency current circulates among the pins without the need for the passive plate Extractable body accessory monopolar 70 The monopolar 70 accessory for body treatments uses monopolar radio frequency technology so the radio frequency current requires use of the passive plate in contact with the body to be able to perform the treatment RF emitters Multipola...

Страница 15: ... the electrode holder for body radio frequency Joint rings Two fixing elements that guarantee the seal tightness of the connection of extractable accessories mainly avoiding liquids or remains of gel entering during its use RF emitter s Applicable part in contact with the patient through which the radio frequency energy is emitted once the electric connection of the accessories is correct as long ...

Страница 16: ... mainly avoiding liquids or remains of gel entering during its use Monopolar facial extractable accessory The monopolar accessory for facial treatments uses monopolar radio frequency technology so the radio frequency current requires the use of a passive plate in contact with the body to close the circuit Parts that comprise the facial electrode holder Accessory connector electric Type of connecti...

Страница 17: ...massage head The following details the parts comprising the mechanical massage head Base of the mechanical massage head Base of the mechanical massage head that allows manual connection disconnection of the massage roller easily and comfortably Massage accessory Rotational applicable extractable part that connects to the base of the head and performs the body massage when that function is activate...

Страница 18: ...op the treatment and to change the turning direction if considered necessary without the need to use the user interface easily and comfortably The mechanical massage head is not used with the pedal Accessories Pasive plate The passive plate is the neutral element that is used in contact with the body in treatments using monopole radio frequency to facilitate passage of the current provided by the ...

Страница 19: ...s recommendable to perform the RF treatments with the pedal With the equipment in play mode the radio frequency emission is activated by keeping one s foot pressed on the pedal Both when placing as well as on lifting the heads from the treatment area on the patient it is very important that the radio frequency emission is disabled pedal not pressed This avoids current false contacts guaranteeing a...

Страница 20: ...e equipment and when its use has finished The remaining accessories must be kept duly in their respective boxes to avoid blows and falls that may give rise to malfunctioning of the equipment Never use a defective head In such a case contact with the technical service Connecting accessories and applicators to the equipment The following scheme details connection of the different accessories and hea...

Страница 21: ...tly for it to make contact Line up the connector slot with the slot on the equipment port to join them Turn the thread shown in the image clockwise until it is perfectly locked Disconnect the head Turn the thread in the image anti clockwise the opposite direction to the image until it unlocks from the machine port Never stretch the connector without having turned the thread to release it After it ...

Страница 22: ...accessories on the relevant facial or body electrode holder one must proceed as follows Align the mechanical connectors of the electrode holder and the accessory male and female respectively and fit the accessory into the head until the connectors lock together At that point the electric connector will automatically be connected by slight pressure until it is fixed in place The function of the joi...

Страница 23: ... and the accessory male and female respectively and fit the accessory into the head until the connectors lock together pressing lightly until fixing them Never press the mechanical massage head with remains of gel on your hands to avoid it malfunctioning Switching on the equipment Before switching on the equipment for the first time carefully read section safety requisites that detail the electric...

Страница 24: ...st connect the cable will be delivered as an accessory TFT Touchscreen The safyre interacts with the operator through a touchscreen Softly press the interactive buttons that appear on the screen to browse the different menus and submenus of the system The touchscreen resistance system is touch sensitive in the different areas so contact with treatment gels and other products must be avoided to min...

Страница 25: ...159 Inspect and clean both the equipment casing as well as the accessories after switching off the equipment To do so see maintenance that explains how to clean and sterilise the equipment and accessories Place the accessories in their holder as described in section Placing the accessories in the holder ...

Страница 26: ...d the treatment commences see Radio frequency mode and Mechanical massage mode To select the common treatment time for both work modes radio frequency mode and mechanical massage mode Use the keys increase time and decrease time of the user interface to program the desired treatment time Use the restore button to restart the treatment time The equipment will return to the last time selected If bot...

Страница 27: ...adio frequency accessory to be used correctly as indicated in Connection of extractable accessories At this point the equipment shall recognise the head and accessories selected so the screen shall display the recognition between for that selection Recognition button The facial recognition button is displayed on screen after a facial head is connected The body recognition button is displayed on sc...

Страница 28: ... the radio frequency mode To work in radio frequency mode it is only necessary to program the power value expressed as a to work with To do so use the keys increase power and decrease power of the radio frequency mode The radio frequency power values may be adjusted from 0 to 100 To start stop the treatment Press the required RF recognition button jack 1 or jack 2 and the required radio frequency ...

Страница 29: ...power emission button displayed is enabled and the active power of RF delivered is shown on screen expressed in W in real time Mechanical massage mode Before using the mechanical massage mode Connect the Mechanical massage head along with its rotating accessory correctly as indicated in Connection of accessories and heads to the equipment RF Jack enabled Treatment ACTIVE Active power emission on t...

Страница 30: ...To start stop the treatment Press the mechanical massage recognition button to select work in that mode This button shall be enabled on the user interface Begin the treatment from the user interface using the Start pause mechanical massage treatment button and it will be marked Press the Start pause mechanical massage treatment button again to stop the treatment Start the treatment using the head ...

Страница 31: ... need to use the user interface in an easy comfortable way When the massage is activated giving a short press changes the rotation direction of the massage head The mechanical massage head is not used with the pedal Active treatment screen During active treatment the treatment button remains enabled Likewise the recognition button is enabled During the active treatment the rotation indicator is en...

Страница 32: ...effect on the skin that helps with the tissue reduction and skin restoration by the radio frequency technology Radio frequency treatments Radio frequency generates an electromagnetic current that penetrates through the tissues in contact with the heads working from the liquid surface layers of tissue to the deeper layer of the epidermis and dermis When it runs through the tissues the current gener...

Страница 33: ...es and thickening of the overlying dermal layer Lastly after the controlled thermal lesion with retraction of the tissue there is an inflammatory response that is accompanied by migration of fibroblasts that shall reinforce the collagen structure even more resulting in rejuvenation of the area treated Effects of radio frequency The procedure by which the current penetrates the tissues and generate...

Страница 34: ...massaging it at low power depending on the client s tolerance of the initial heat After heating up the power is progressively raised until completing the treatment reaching a temperature on the skin that allows the desired effect for the treatment to be obtained Always work at a power according to the client response to the heat generated The movements during the treatment must be upward with pres...

Страница 35: ...n contact with the patient s body it is recommended to work depending on the treatment zone or circular with pressure or work alternating upward movements with pressure and downward without pressure in order to achieve contouring and firming up of the beneficial tissue Each one of the treatment images details the recommended massage mode Contraindications Precaution Women who use IUD Metal implant...

Страница 36: ... first 48 h of post surgery for certain pathologies Bearers of metallic prostheses Patients with malign neoplasy Persons who are not temperature sensitive Active infectious processes Persons who suffer from uncompensated arthropathies Secondary effects Redness on the area treated Feeling of high heat in the area treated for 30 minutes after the treatment ...

Страница 37: ...ly for acrylic surfaces Cleaning and sanitizing applicators after each treatment device is encouraged To do this remove remaining product gel deposited on the applicator after each treatment and clean and disinfect the applicator before using again Do not use products containing alcohol for cleaning applicators After cleaning the outside of the housing dry all parts thoroughly using synthetic fabr...

Страница 38: ... POWER 150 W RADIO FREQUENCY POWER 1 MHz POWER POWER Single phase 100 240 V MAINS FREQUENCY 50 60 Hz MAXIMUM POWER 300W REGULATION Class to IEC 60601 1 Class I Type BF DIRECTIVE 2006 95 EEC LVD on low voltage DIRECTIVE 2994 108 EEC EMC on electromagnetic compatibility DIRECTIVE 2002 95 EEC RoHS DIRECTIVE 2002 96 EEC RAEE PHYSICAL CHARACTERISTICS DIMENSIONS 430 x 300 x 400 mm DIMENSIONS WITH STAND ...

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