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User manual Facial rejuvenation and body contouring in a single device...
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INTRODUCTION The purpose of this manual is to provide the safyre user with the information on the instructions for use, treatments, controls, safety precautions, installation and maintenance of the equipment, aiding use and care of the system. Adequate training by qualified staff is indispensable to apply treatments using this equipment.
The CE mark accredits compliance with the European Directive applicable to the device. Electrical safety requisites The safyre equipment is designed and intended for continuous operation, allowing it to operate on universal mains voltage of 100 – 240 V, 50 – 60 Hz.
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Should that happen, the safyre must be observed to check its correct operation.
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If the waste is to be removed in an unsuitable way, it is possible that some parts of the product may have potentially negative effects on the environment and human health. In case of faulty product abuse, sanctions are foreseen. Página 46 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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Present in the user interface, the appearance of this symbol during a normal usage of the device means that you should consult the user manual before any further action. Symbol 5.12 EN280 - Information Symbol manufacturer. Página 47 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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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 sanitary device according IEC980:2009 harmonized standard. Página 48 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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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. Página 49 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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STORAGE, HANDLING AND TRANSPORTATION Location and transport of the device Due to the weight of the device, safyre may cause injury if not moved with the necessary care. safyre is designed to work with a mobile stand, although it may be used without that stand as table top equipment.
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Keep the original packaging of the device during the first 30 days of use as changes shall not be accepted without delivery of the equipment in the original packaging during that period. Página 51 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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Massager accessory Glycerin (dermic gel Pedal Guarantee User and packaging English and Castellan Display safyre certificate manuals protocols Conformity 1 declaration Página 52 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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GENERAL DESCRIPTION OF THE DEVICE AND HANDPIECES External description of the device The safyre device is comprised of a central unit and a series of radio frequency heads, with extractable accessories and mechanical massage. safyre also includes accessories for patient safety during the treatment.
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Description of the applicators and accessories safyre includes a series of radio frequency heads, both for bodily as well as facial use, with multiple extractable accessories, and an head to perform the mechanical massage function just as described below. It is essential to clean the extractable radio frequency accessories and the mechanical massage heads using a damp cloth to avoid gel accumulation at the end of each treatment.
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Accessory connector (Mechanical) RF emitter Joint rings Accessory connector (Electrical) Monopole Accessory Página 55 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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Radio frequency facial head Internal connector Internal connector head head (electric) (mechanical) Joint rings RF facial electrode holder Parts that comprise the facial electrode holder: Página 56 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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RF emitter/s: Applicable part in contact with the patient through which radio frequency energy is emitted once the electric connection to the accessories is correct (as long as the radio frequency emission is activated). Página 57 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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Push button: Head push button that allows activation /deactivation of the massage and modification of the turning direction of the roller. Página 58 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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Guaranteeing good contact of those emitters avoids any kind of adverse effect on the patient during application of the treatment. Surface in contact with the patient Passive plate Página 59 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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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 safe treatment. Página 60 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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 heads to the SAFYRE equipment, before beginning the treatment: Mechanical massage...
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In the case of disconnection of the accessory or the head during treatment, the recognition button will disappear. Página 62 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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The function of the joint rings is to guarantee the seal tightness of the head, to avoid liquid or gel getting inside the head cavity and being able to cause malfunctioning of the head electric connections. Página 63 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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Página 64 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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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 minimize damage and wear of the screen.
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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. Página 66 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
If both a radio frequency head and the mechanical massage head have been connected, the treatment time is common to both modes. Use the code and license button to access the code screen. It is only for technical service. Página 67 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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The facial recognition button is displayed on screen after a facial head is connected. The body recognition button is displayed on screen after a body head is connected. Página 68 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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Press the Start/pause RF treatment button again to pause the treatment. RF treatment starts/ pause button If the pedal is used, activate/deactivate the pedal to start/pause the radio frequency treatment. Página 69 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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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. Página 70 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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(the Start/pause mechanical massage treatment button is activated no the user interface). A long press on the trigger is again is to stop the mechanical massage (disabling the Start/pause mechanical massage treatment button on the user interface). Página 71 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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Active rotation indicator During active treatment, the treatment button remains enabled. Likewise, the recognition button is enabled. During the active treatment, the rotation indicator is enabled. Página 72 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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The main result is rejuvenation of the skin, cell strengthening and a greater firmness of the tissue. safyre also includes a mechanical massage so, using a speed and direction adjustable rotational head, it achieves a massage-tensing effect on the skin that helps with the tissue reduction and skin restoration by the radio frequency technology.
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Once this first heating is performed, the power may be raised progressively by intensifying the treatment. The final power must always be adapted to the client’s response to the treatment. Página 74 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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First heat the treatment area for a brief space of time, massaging it at a low power (depending on the client’s tolerance of the initial heat). Página 75 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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Electric and electronic implants, either internal or connected to the exterior, with batteries or controlled by radio, such as: pacemaker, neurostimulators, drug dosage devices, cochlear hearing implants or external monitoring devices Internal haemorrhage processes in acute phase Página 76 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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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 Página 77 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
High Technology Products, SL specialized technical staff. Do not immerse the handpiece in liquid Página 78 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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DIMENSIONS WITH STAND (optional) 403 x 1015 x 500 mm WEIGHT 20 Kg SCREEN Touchscreen 10, 4 “ WORK RANGE 18-30 °C 2-50 °C <90% Humidity (without condensation) Página 79 de 119 safyre - Manual de usuario/User manual/Manuel de l’utilisateur MKT-07-M1/20160623/MAN00159...
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