Sensica Sensifirm Indications For Use Download

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Table of Contents

Indications for Use

Intended use of Sensifirm

Safety

Sensifirm device description

When Sensifirm should not be used

User Instructions

Device Set-Up

Preliminary Test

How to use Sensifirm device

Recommended treatment protocol

Treatment areas

Cleaning

Troubleshooting

Customer Service

Device Specifications

Possible Side Effects

What is Sensifirm?

How does it work?

4
4

Hand-held description
User interface description

CONTRAINDICATIONS
WARNINGS
CAUTIONS

What to expect when using Sensifirm

Post-treatment care

Englis

Electromagnetic compatibility (EMC) and Specifications

How to prepare yourself

Summary of Contents for Sensifirm

Page 1: ...treatment protocol 15 16 Treatment areas 17 17 18 18 Cleaning 20 Troubleshooting Customer Service All rights reserved to EL Global Trade Ltd 3 Device Specifications Possible Side Effects What is Sensifirm How does it work 4 4 Hand held description User interface description 7 8 CONTRAINDICATIONS WARNINGS CAUTIONS What to expect when using Sensifirm Post treatment care 16 English Electromagnetic co...

Page 2: ...e useful for various applications including improving cellulite appearance The Sensifirm houses a vibration motor which causes a gentle massage sensation as you move the device over your skin RF technology Radio Frequency RF is a form of electromagnetic energy that has been used for a long time in aesthetic medicine The spacing between Sensifirm s four RF electrodes enables great treatment volume ...

Page 3: ...ment and is intended for a single user Safety Sensifirm is designed to protect your skin The device has two built in sensors which constantly measure your skin temperature When the temperature rises to the maximal level 41o C 106 7o F the RF energy heat will automatically stop When the temperature has decreased again the RF energy heat will be automatically re activated The temperature sensors pre...

Page 4: ...ce status ON OFF Base Gel Designed specifically to improve contact between the device and the skin and to improve skin conductivity to ensure proper delivery of RF energy and best possible results DO NOT use Sensifirm without first applying the Base Gel as this will compromise your safety and treatment efficacy Base Gel ingredients Glycerin Aqua Phenoxyethanol Ethylhexylglycerin Triethanolamine an...

Page 5: ...English 7 Hand held description Status indicator RF electrodes RF energy selection button 1 3 energy level lights RF electrodes RF electrodes Temperature sensors Power Socket ...

Page 6: ...rgy level selection button repeatedly until you reach the desired level 1 2 3 or off User interface description Note RF energy is delivered only when proper contact with your skin is detected When proper treatment is underway the status indicator will have a steady green light and you will feel vibration Upon contacting the treatment area the massage function is automatically turned on RF energy l...

Page 7: ...se the Sensifirm device if any of the following conditions apply If you suffer from blood clotting disorders excessive bleeding or bruising damaged wound healing or if you routinely take blood thinning medications If you suffer from a history of deep vein thrombosis If you have a history of collagen disorders or suffer from keloid scarring growth of extra scar tissue where the skin has healed afte...

Page 8: ...had esthetic injections of fillers such as hyaluronic acid collagen fat or Botox in the treatment area If you have any metal items such as jewelry or piercings or tattoos or permanent make up on the designated treatment areas If you have sunburn or dark brown or black spots such as freckles birth marks moles or blisters in the treatment area If you are allergic or sensitive to chrome or nickel or ...

Page 9: ...ers basins or other vessels containing water as this may cause severe electrocution Do not leave Sensifirm unattended while plugged into the electricity supply as it may lead to electrocution Keep out of reach of children and pets Use the Sensifirm only in accordance with these Instructions for Use and for the intended use Do not use the device if any part of the device is missing damaged or loose...

Page 10: ...ith your physician if any of these side effects occur Degree of Side Effects Side Effects Minor Rare Extremely Rare Local pain Skin irritation Skin redness Minor swelling Skin sensitivity Allergies or sensitivity to Base Gel Mild skin burns Pigment changes Excessive redness rash swelling Subcutaneous bleeding Severe burns Infection Bruising Blistering The use of the Sensifirm device is simple and ...

Page 11: ...Prepare the treatment area Make sure your skin is dry clean and free of topical products such as moisturizers and lotions Caution Never use flammable liquids such as alcohol including perfumes sanitizers or other applications containing alcohol or acetone to clean the skin in the hour before using Sensifirm as it may cause burning of the skin Remove all jewelry from the treatment area Remove exces...

Page 12: ... a warm sensation on your skin However if you feel your skin is heating up too fast reduce the RF energy level adjusting it to suit your own comfort Stop the test immediately if you do not feel comfortable or if you see adverse effects such as severe redness or blistering Wait 48 hours and examine the tested area 1 2 3 4 5 6 If the skin in the test area seems normal no adverse effects you can proc...

Page 13: ...ing down After the light has turned off unplug the device from the electrical outlet After completing the treatment wipe off any remaining Base Gel from the treated area 3 4 5 6 7 8 Clean the device with a soft damp cloth or paper towel according to the cleaning instructions in the Cleaning section below Recommendedtreatment protocol For long lasting results use Sensifirm once a week on each treat...

Page 14: ...n the Preliminary test section above Note For your own comfort it is recommended to perform the treatments of all areas while lying down Post treatment care After completing the treatment wipe off the remaining Base Gel from the treated area Do not expose the treatment area to direct sun light without applying a high factor sunscreen at least 30 SPF Uncontrolled sun exposure might cause your skin ...

Page 15: ...eep it clean and stored in its original box If you plan to travel and take your Sensifirm with you you should store it in the original box and follow the maintenance instructions 3 4 5 Troubleshooting If you experience any problems with your Sensifirm please refer to the information below Make sure that the power cord is plugged in properly to the electrical outlet and into the device socket Make ...

Page 16: ...ken or stops working if you need assistance or if you would like to order more Base Gel for additional treatments or if your Base Gel has expired please contact us 855 SENSICA 855 736 7422 support sensica com Device specification parameters The RF handheld device is powered by multipolar RF at 10 1 Watt Frequency 1 0 05 MHz Selectable output power level 3 levels Temperature sensors RF heating is a...

Page 17: ... RH Humidity 10 000 ft Max Operating Altitude 10 0C to 70 0C 140F to 1580F 10 to 90 RH at 550C 1310F 100C to 400C 500F to 1040F Labeling Model CEL100xxyyzzz Power 9V 1 5A 100 240VAC 50 60Hz Double insulation Consult Instructions for use Do not dispose Please read all warnings and safety precautions prior to use Keep dry Type BF equipment Do not use the Sensifirm device on sensitive tanned skin or ...

Page 18: ...nce will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encourage to try to correct the interference by one or more of the following measures a Reorient or relocate the receiving antenna b Increase the separation between the equipment and receiver c Con...

Page 19: ...nal antennas should be used no closer than 30cm 12 inches to any part of the Sensifirm including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result The use of accessories or replacement parts other than those sold specified by Sensica International may result in increased emissions or decreased immunity of the Sensifirm The Sensifirm should...

Page 20: ...issions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Group 1 Class B Class A Complies The Sensifirm emits electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected The Sensifirm is suitable for use in all establishments including domestic establishments and those directly connected to the public lo...

Page 21: ...ommercial or hospital environment Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s Mains power quality should be that of a typical commercial or hospital environment If the user of the Sensifirm requires continued operatio...

Page 22: ...itter Recommended separation distance d 3 5 3 P 1 17 P d 3 5 6 P 0 58 P d 3 5 10 P 0 35 P 80 MHz to 800 MHz d 7 10 P 0 7 P 800 MHz to 2 7 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site su...

Page 23: ...gnetic environment in which radiated RF disturbances are controlled The customer or the user of the Sensifirm can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Sensifirm as recommended below according to the maximum output power of the communications equipment Separation distance according to...

Page 24: ...26 ...

Page 25: ...eliminar 38 Cómo utilizar el dispositivo Sensifirm 38 Protocolo de tratamiento recomendado 39 40 Zonas de tratamiento 41 41 42 42 Limpieza Solución de problemas Servicio de atención al cliente Especificaciones del dispositivo Posibles efectos secundarios Qué es Sensifirm Cómo funciona 28 28 Descripción del dispositivo manual Descripción del interfaz del usuario 31 32 CONTRAINDICACIONES ADVERTENCIA...

Page 26: ... de masaje es útil para diversas aplicaciones también para mejorar la apariencia de la celulitis El dispositivo Sensifirm contiene un motovibrador que produce una suave sensación de masaje cuando se mueve sobre la piel Tecnología de RF La radiofrecuencia RF es una forma de energía electromagnética usada desde hace tiempo en la medicina estética La distancia ente los cuatro electrodos de RF de Sens...

Page 27: ...ositivo tiene dos sensores incorporados que controlan en todo momento la temperatura de su piel Cuando la temperatura suba a un nivel máximo de 41o C 106 7o F la energía de RF se detendrá automáticamente Cuando la temperatura vuelva a bajar la energía de RF calor se activará automáticamente Los sensores de temperatura evitan el exceso de calentamiento local Siga este Manual de instrucciones para q...

Page 28: ... del dispositivo ON OFF Gel Base Especialmente diseñado para mejorar el contacto entre el dispositivo y la piel y la conductividad de la piel de modo que la energía de RF se transmita de manera adecuada y produzca los mejores efectos posibles NO use Sensifirm sin haber aplicado antes el gel de base porque puede comprometer su seguridad y la eficacia del tratamiento Ingredientes del gel de base Gli...

Page 29: ...escripción del dispositivo manual Indicador de estado Electrodos de RF Botón de selección de energía de RF Luces de nivel de energía 1 a 3 Electrodos de RF Electrodos de RF Sensores de temperatura Toma de corriente ...

Page 30: ...e selección de nivel de energía de RF repetidamente hasta que alcance el nivel deseado 1 2 3 o apagado Descripción del interfaz del usuario Nota Solamente se transmite la energía de RF cuando se detecta contacto con la piel Cuando el tratamiento está en curso el indicador de estado tendrá una luz verde fija y usted sentirá una vibración Al contactar con la zona a tratar se activa automáticamente l...

Page 31: ...sa medicamentos que influyan en su sistema NO utilice el dispositivo Sensifirm en ninguno de los casos siguientes inmunológico Si padece coagulopatía o hemorragias o excesivos hematomas o mala cicatrización de las heridas o si toma habitualmente medicamentos anticoagulantes Si tiene antecedentes de trombosis venosa profunda Si tiene antecedentes de trastornos de colágeno o se le producen cicatrice...

Page 32: ...stiramiento de la piel liposucción peeling profundo criolipolisis congelación de grasa o si le han efectuado inyecciones o rellenos estéticos como los de ácido hialurónico colágeno grasa o bótox en la zona a tratar Si tiene elementos metálicos como pendientes joyas o piercing o tatuajes o maquillaje permanente en la zona a tratar Si tiene quemaduras solares manchas marrones o negras como pecas mar...

Page 33: ...bos u otros contenedores de agua pues puede electrocutarse No deje el dispositivo Sensifirm solo cuando esté enchufado pues puede haber riesgo de electrocución Manténgalo lejos del alcance de niños y mascotas Utilice Sensifirm únicamente de acuerdo con este Manual de instrucciones y para el uso previsto No utilice el dispositivo si falta está deteriorado o se ha perdido alguno de los componentes d...

Page 34: ...rio Grado de los efectos secundarios Efectos secundarios Menores Infrecuentes Extremadamente infrecuentes Daño localizado Irritación de la piel Enrojecimiento de la piel Pequeña inflamación Sensibilidad cutánea Alergia o sensibilidad al gel de base Quemaduras de la piel leves Cambios en la pigmentación Quemaduras graves Infección Moratones Ampollas El uso del dispositivo Sensifirm es sencillo y rá...

Page 35: ... prepararse 1 2 3 4 Prepare la zona a tratar Asegúrese de que su piel está seca limpia y libre de productos tópicos como hidratantes o lociones Cuidado No utilice nunca líquidos inflamables como alcohol incluidos los perfumes desinfectantes y otros productos que contengan alcohol ni acetona para limpiar la piel una hora antes de usar Sensifirm pues puede causar quemaduras en la piel Elimine todas ...

Page 36: ...que le resulte más cómodo Detenga la prueba en cuanto no se sienta cómodo o si observa efectos no deseados como enrojecimiento o ampollas 1 2 3 4 5 Espere 48 horas antes de volver a examinar la zona de la prueba Si la piel de la zona de la prueba tiene aspecto normal sin efectos indeseados puede realizar el tratamiento completo con los niveles de energía que le resulten más cómodos Nota El nivel d...

Page 37: ...esplazar Sensifirm a una zona a tratar menor o aumente la energía de RF Al final de cada sesión de tratamiento apague el 2 3 4 5 6 7 8 dispositivo presionando el botón de selección de energía Una luz indicadora naranja se encenderá mientras el dispositivo se apaga Una vez apagada la luz desconecte el dispositivo de la red eléctrica Una vez completado el tratamiento limpie los restos de la base Sen...

Page 38: ...los restos del gel de base que queden en la zona tratada No exponga las zonas tratadas a la radiación solar sin antes aplicar un protector solar con factor de protección alto al menos un factor de protección solar 30 Una exposición al sol excesiva puede hacer que su piel se vuelva sensible Durante los dos días posteriores al tratamiento evite aplicar agua caliente sobre su rostro y no use producto...

Page 39: ...nal Si tiene previsto viajar y 3 4 5 Solución de problemas Si experimenta algún problema con Sensifirm consulte la información que figura a continuación para intentar resolverlo Asegúrese de que el cable de alimentación está conectado adecuadamente a la red eléctrica y a la toma de corriente del dispositivo Asegúrese de que la toma eléctrica tiene corriente a b Si Sensifirm no emite señal de energ...

Page 40: ...a ayuda o si quiere realizar un pedido adicional de gel de base para tratamientos 855 SENSICA 855 736 7422 support sensica com Especificaciones del dispositivo El dispositivo manual de RF está alimentado por RF multipolar a 10 1 vatios Frecuencia 1 0 05 MHz Posible nivel de potencia de salida 3 niveles Sensores de temperatura El calor de la RF se desactiva automáticamente cuando la temperatura de ...

Page 41: ...firm solo con la fuente de alimentación original Para su seguridad no utilice nunca adaptadores que no hayan sido aprobados por el fabricante Instrucciones de almacenamiento Condiciones de transporte y almacenamiento Temperatura Humedad Sin condensación Presión Condiciones de funcionamiento Temperatura 30 al 70 Humedad 3 000 m Altitud máxima operativa 10 0C a 70 0C 140F a 1580F 10 a 90 HR a 550C 1...

Page 42: ...44 Fecha del tratamiento Zona tratada Comentarios Treatment log Registrodetratamiento Treatment date Treated area Comments ...

Page 43: ...45 Fecha del tratamiento Zona tratada Comentarios Treatment log Registrodetratamiento Treatment date Treated area Comments ...

Page 44: ...46 Fecha del tratamiento Zona tratada Comentarios Treatment log Registrodetratamiento Treatment date Treated area Comments ...

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