HF IBRAMED
Contents
1. DIRECTIONS FOR TREATMENT PERFORMANCE 1 Clean the skin and apply the electrode on the skin fluxation or brief touches on the skin direct sparkling 2 Demonstrate the technique to the patient before initiating procedure 3 The larger and smaller spherical electrodes may be used in the fluxation or sparkling techniques however before placing the electrode on the patient the therapist must touch the extremity of the electrode with the tip of the fingers and remove it only after the contact with the patient s skin This avoids the occurrence of an electrical discharge to the patient which might frighten the patient 4 The fork electrode is used in direct sparkling or neck fluxation on the arms neck breasts etc to facilitate the access to these areas 5 The saturator electrode is used in indirect sparkling The application technique is performed by the patient holding the saturator glass electrode while the therapist promotes manual stimuli on the treatment area 6 The cauterizing electrode is used in direct sparkling for hemostasis of acne lesions This electrode concentrates charge on its tip 7 Comb electrode used for alopecia lesions and other affected scalp areas Always apply over dry hair Comb the hair with the comb electrode in all directions using the fluxation technique Attention Avoid contact with the HF pen extremity where it connects to the glass electrode because dangerously intense sparks might occur2. Magnetic Field in the frequency of Power feed 50 60 Hz IEC 61000 4 8 NOTE U is the power AC voltage before the application of the trial level Level of the trial IEC 60601 lt 5 U gt 95 of tension fall in U per 0 5 cycle 40 U 60 of tension fall in U per 5 cycles 70 U 30 of tension fall in U per 25 cycles lt 5 U gt 95 of tension fallin U per5 seconds Level of Conformity lt 5 U gt 95 of tension fall in U per 0 5 cycle 40 U 60 of tension fall in U per 5 cycles TITO ig 30 of tension fall in U per 25 cycles 5 Uae gt 95 of tension fallin U per5 seconds 15 Electromagnetic Environment directions The quality of the power supply should be equivalent to the one of a hospital or a typically commercial establishment If the user of the equipment requires continuous operation during energy interruption it is recommended that the equipment should be fed by a source of uninterrupted power supply or a battery Magnetic fields in the frequency of power supply must be on the same levels characteristic of a hospital environment or a typically commercial establishment ELECTROMAGNETIC COMPATIBILITY Directions and Manufacturer s Statement electromagnetic immunity The HF IBRAMED electro stimulator is destined for use in the electromagnetic environment specified below The user of the equipment must ensure
3. Always hold the body of the HF pen Never hold the pen cable Asepsis Wash the glass electrodes with current water and soap and then dry them with paper towels This type of electrode is self cleaning the ozone production itself will provide sterilization 22 GLASS ELECTRODES APPLICATORS HIGH FREQUENCY For facial body capillary and podology treatments there OPTIONAL GLASS ELECTRODES WHICH MAY are many different types of glass electrodes making it BE USED difficult to describe all of them here Below we describe the most commonly used types of electrodes e J me a 5 E EEEE SS GLASS ELECTRODES WHICH ACCOMPANY Figure 3 A small spherical glass electrode used in direct HF IBRAMED sparkling or fluxation Before attaching the spherical glass electrode to the patient place one fingertip on the extremity A of the pen and only remove it when the electrode is in gt contact with the patient s skin ls dais Figure 4 Fork glass electrode used in direct sparkling or DH fluxation in curved treatment areas such as neck arms breasts armpits etc Figure 2 A larger spherical type electrode used in direct sparkling or fluxation Before attaching the E RA spherical electrode to the patient place one fingertip on the extremity of the pen and only remove it when Figure 5 Saturator glass electrode used in indirect the electrode is in contact with the p
4. IEC 61000 3 3 13 ELECTROMAGNETIC COMPATIBILITY Directions and Manufacturer s Statement electromagnetic immunity The HF IBRAMED electro stimulator is destined for use in the electromagnetic environment specified below The user of the equipment must ensure that it is used in such an environment Level of the trial IEC 60601 Immunity Trial Electromagnetic Environment directions Level of Conformity Electrostatic Discharge 6 kV per 6 kV per contact The flooring must be either wooden concrete or ESD contact 8 kV by air ceramic If the flooring is covered with synthetic 8 kV by air material the humidity must be of least 30 IEC 61000 4 2 Rapid electric 2 kV in the 2 kV in the The quality of the power supply should be equivalent transitory train Power lines Power lines to the one of a hospital or a typically commercial pulse 1 kV in the 1 kV in the establishment Burst input output input output lines IEC 61000 4 4 lines Surges 1 kV differential 1 kV differential The quality of the power supply should be equivalent mode mode to the one of a hospital or a typically commercial es TEC 61000 4 5 2 kV regular mode 2 kV regular mode tablishment 14 ELECTROMAGNETIC COMPATIBILITY Immunity Trial Voltage falls short interruptions and voltage variations in the input power lines IEC 61000 4 11
5. must have their level of consciousness preserved PART OF THE BODY OR TISSUE ON WHICH IT IS APPLIED OR WITH WHICH 1T INTERACTS Areas of the torso except precordial region upper and lower limbs face neck and d collet except thyroid region USERS PROFILE e Este dispositivo debe ser usado solamente bajo prescripci n y supervisi n de un profesional de la salud diplomado e Este dispositivo no necesita de capacitaci n especializada sin embargo el usuario de este dispositivo debe leer comprender y practicar las instrucciones de precauci n y funcionamiento e El usuario debe conocer las limitaciones y peligros asociados con el uso de dispositivos electr nicos y observar las etiquetas de precauci n y operacionales colocadas en esta unidad e El usuario debe seguir las informaciones contenidas en estas instrucciones de uso para la modalidad de tratamiento disponible as como las indicaciones contraindicaciones advertencias y precauciones e El usuario debe tener ntegras sus funciones cognitivas e El usuario debe tener ntegras las funciones motoras necesarias para el manejo de este equipo e En relaci n a la movilidad este equipo es considerado en equipo portatil RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT The use of electromedical equipment is restricted to a physician or under his command the physical therapists or health professionals properly licensed The professional will be responsible for
6. service according to the EMC information provided in the following tables Portable and Mobile Radio Frequency RF communications equipment can affect Medical Electrical Devices AN WARNING The use of accessories other than those listed except when supplied or sold by Ibramed Ind stria Brasileira de Equipamentos M dicos Ltda as replacement parts for internal or external components may result in increased emission or decreased immunity of the HF IBRAMED Electro Stimulator 12 ELECTROMAGNETIC COMPATIBILITY Directions and Manufacturer s Statement electromagnetic emissions The HF IBRAMED electro stimulator is destined for use in the electromagnetic environment specified below The user of the equipment must ensure that it is used in such an environment Emission Essay Compliance Electromagnetic Environment directions RF Emissions HF IBRAMED stimulator uses RF energy only for its internal Group 1 functions However its RF emissions are very low and unlikely to NBR IEC CISPR 11 cause any interference in nearby electronic equipment IEC CISPR 11 RF Emissions NBR IEC CISPR 11 Class A IEC CISPR 11 HF IBRAMED electrostimulator is adequate for use in all premises which are not residential and not directly connected Harmonics Emission to the public low tension electric power distribution line which Class A supplies buildings appropriate for domestic use IEC 61000 3 2 Emissions due to tension fluctuation scintillation Class A
7. that it is used in such an environment Immunity Trial BENG PNE triak Electromagnetic Environment directions IEC 60601 of Conformit RF Communication equipment portable or mobile must not be used next to any part of HF IBRAMED including cables with a separation distance of less than the recommended calculated from the equation applicable to the frequency of the transmitter Separation distance recommended 3 Vrms RF Conducted R d 1 2 IEC 61000 4 6 150 kHz to 80 MHZ d 0 35 800 MHz up to 800 MHz d 0 7 800 MHz up to 2 5 GHz Where P is the maximum output nominal potency of the 80 MHz to 2 5 GHz 10 V m transmitter in watts W according to the manufacturer of the equipment and d is the separation distance recommended in meters m It is also recommended that the Field intensity established by the RF transmitter as determined by an electromagnetic inspection at the site should be lower than the conformity in each frequency band Interference around the equipment marked with the following symbol might occur RF Radiated 10 V m IEC 61000 4 3 ELECTROMAGNETIC COMPATIBILITY NOTE 1 In 80 MHz and 800 MHz highest frequency band is applied NOTE 2 These directions may not be applicable in all situations The electromagnetic propagation is affected by the absorption and reflection of structures objects and people The Field intensities established by the fixed transmitters such as base radio stations tel
8. 0 Hz just by converting the 110 220 volt key located on the cabinet rear power feed panel The equipment has an internal accessible to the user protection fuse not NOTE never open the electrical power feed and or the HF application pen in the equipment There are dangerous tensions present inside these parts 21 HF HIGH FREQUENCY In the High Frequency mode glass electrodes filled with special gas are used as a conductor mean to electrical stimulation The equipment generates an alternated current of some thousands of volts low current which is applied to this glass electrode The gas inside the electrode is then excited producing small electrical sparks on the external face of the glass electrode During this process of electrical sparks ozone is generated and the properties of ozone oxygenating fungicide bactericide and viral inactivation are used in this type of treatment The ozone is a reactive type of oxygen Oxygen 0 in nature is composed of only two atoms while ozone O is composed of three atoms At room temperature ozone is an invisible gas with a characteristic odor For the treatment a so called HF pen is used Itis to this pen that the glass electrodes are connected These electrodes present differentiated shape to adequate themselves to the treatment areas For the treatment a so called HF pen is used It is to this pen that the glass electrodes are connected Figure 1 HF Ibramed Pen
9. Da y a O E IBRAMED QUEST O DE RESPEITO HF IBRAMED Manufactured by IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI Made in Brazil ANVISA N 10360310020 2th edition REV 03 2012 TABLE OF CONTENTS FIGURES SLOSSAR Munic 3 CEFAI IBRAMED CENTER FOR EDUCATION AND SYMBOL DEFINITION S msi gerar mg cede eos 4 ADVANCED TRAINING 30 PREFACE dee 5 PRODUCT DESCRIPTION WEE 5 PRECAUTIONARY DEFINITIONS 6 SAFETY PRECSUTI N Scenes 6 INDICATIONS AND CONTRAINDICATIONS 8 PATIENT PROFILE USERS PROFILE AND TREATMENT AREA 9 RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT 10 ENVIRONMENTAL PROTECTION ccc cee eee eens eee eeeee eee 11 ELECTROMAGNETIC COMPATIBILITY GUIDANCE 12 ELECTROMAGNETIC COMPAIIBIEMT Vitvcunesraeneursasatcanceesot 13 NOMENCEAL UR EE 19 SYSTEM SPECIFICA TONS qua ido ia a a 20 SPECIFICATION capex essa rra ae 20 HF IBRAMED ELECTRICAL POWER FEED 21 AF HIGA FREQUENCY EE 21 DIRECTIONS FOR TREATMENT PERFORMANCE 22 GLASS ELECTRODES APPLICATORS HIGH FREQUENCY 23 TURNING ON THE HF IBRAMED cosido 25 ACCESSORIES WHICH ACCOMPANY HF IBRAMEI 26 BRECH He LEE ER LEE ES MAINTENANCE WARRANTY TERMS AND TECHNICAL SUPPOR EE 28 FIGURES GLOSSARY Figure 1 HF Ibramed ben 21 Figure 2 A larger spherical type electrode used in direct sparkling orfluxation Before attaching the spherical electrode to the patient place one fin
10. ED itself or any other specifically designated by the manufacturer 4 The warranty does not include damages that the product may suffer as a result of a During the installation or use the recommendations of these specifications and instructions are not followed b Accidents or natural agents connection of electrical systems with inappropriate voltages and or subjected to excessive fluctuations or overloading MAINTENANCE WARRANTY TERMS AND TECHNICAL SUPPORT TECHNICAL ASSISTANCE c The unit has been used carelessly or has received Any question or malfunction with your equipment changes modifications or repairs made by unauthorized please contact our technical department persons or technical centers Call 55 19 3817 9633 d There is removal or alteration of the serial number of the device e Transportation accidents OG DANGER 5 The statutory warranty does not include installation No change in this equipment is allowed Any cost of the product shipping of the product to the factory unauthorized modification can affect the safety or authorized retailer cost of labor materials parts and use of this equipment adjustments necessary for the local preparation for the Never make unauthorized repairs installation of the equipment such as the main power line masonry hydraulic network grounding and adaptations 6 The warranty does not include parts subjected to natural wear such as command control keys hand
11. atients skin sparkling It increases the vascularization of the skin It B Comb glass electrode used for capillary treatment is normally applied with oils and skin nutrition creams T 23 GLASS ELECTRODES APPLICATORS HIGH FREQUENCY Figure 6 Correct position for the patient to hold the saturator glass electrode while the therapist performs manual stimulation on the treatment area Figure 7 Cauterizing glass electrode used in direct sparkling for acne hemostasis 24 TURNING ON THE HF IBRAMED 1 Before connecting the HF pen check if the on off switch and the high frequency intensity key are in the OFF position 2 Turn on the HF power feed equipment to the local power line outlet Read the chapter HF Ibramed Electrical Feed before doing so Cr Connect the glass high frequency applicator to the tip of the HF pen 4 Now the intensity of the High Frequency can be increased by turning this switch clockwise and it can be decreased by turning this switch anticlockwise 5 At the end of treatment turn off the equipment turning the intensity control anticlockwise until the position OFF you will hear a CLICK Note If the HF IBRAMED not going to be used remove the electrical power feed from the power line 25 ACCESSORIES WHICH ACCOMPANY HF IBRAMED HF IBRAMED contains accessories designed to satisfy the demands of electromagnetic compatibility CODE QUANTITY PRODUCT 03026016 Comb electrode fo
12. cording to the best and latest clinical criteria CEFAI takes into account the personal and professional development of all its partners and customers IBRAMED A matter of respect CEFAI invites both students and professionals in the fields of Physical Rehabilitation Esthetics Physiotherapy Dermatology and Esthetic Medicine to take part in free courses workshops and the best Postgraduate Lato Sensu courses in the areas of physical rehabilitation and esthetics GC CEFAI sonmacio unn ada IBRAMED 30 a O E IBRAMED QUEST O DE RESPEITO Manufactured by IBRAMED Ind stria Brasileira de Equipamentos M dicos EIRELI Av Dr Carlos Burgos 2800 Jd It lia 13901 080 Amparo SP Brazil phone 55 19 3817 9633 www ibramed com br ibramed ibramed com br
13. d stored at temperatures between 41 F and 122 F 5 C and 50 C Avoid damp and dusty environments e Check cables and associated connectors before each use e The HF IBRAMED Electro Stimulator is not designed to prevent the infiltration of water or other liquids The infiltration of water or other liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient e Disconnect the power plug from the outlet when left unused for long periods of time T SAFETY PRECAUTIONS e Be sure the unit is grounded by connecting it to a grounded electrical outlet compliant with the applicable national and local electrical codes e Prior to patient treatment become familiar with the operating procedures for each mode of treatment available as well as the indications contraindications warnings and precautions Consult other resources for additional information regarding the applications of Electrotherapy e To prevent electrical shock disconnect the unit from the power source before performing any maintenance task e Stimulation should not be applied on or near cancerous lesions e Patients with an implanted electrical device should not be treated with high frequency INDICATIONS AND CONTRAINDICATIONS INDICATIONS OF USE e Facial capillary and podology treatments e Local tumor e Acne skin and podal lesion treatments e Unbalanced diabetes or hypertension e Cauteri
14. ephone cellular wireless and mobile terrestrial radios radio amateur transmission radio AM and FM and TV transmission cannot be theoretically predicted with accuracy To evaluate the electromagnetic environment due to fixed RF an electromagnetic it is recommended to check the local If the field intensity measurement at location where HF IBRAMED s used exceeds the level of conformity used above the equipment must be observed in order to verify whether the operation is normal IF an abnormal performance is observed additional procedures may be necessary such as reorientation or the reinstalling of the equipment Above 150 KHz to 80 MHz frequency band the field intensity should be lower than 10 V m 17 ELECTROMAGNETIC COMPATIBILITY Recommended Separation Distances between portable and mobile RF and HF IBRAMED The HF IBRAMED electro stimulator is conceived to be used in electromagnetic environments in which RF disturbances are controlled The user of the electrostimulator may help to prevent electromagnetic interferences by keeping a minimum distance between the portable and mobile RF communication equipment transmitters and HF IBRAMED as recommended below according to the maximum potency of the communication equipment Maximum Nominal Distance of Separation in accordance with the frequency of the transmitter Output potency of the dera 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 24P d 0 35 VP d 0 7 VP Fo
15. gertip on the extremity of the pen and only remove it when the electrode is in contact with the patients skin B Comb glass electrode used for capillary EE 23 Figure 3 A small spherical glass electrode used in direct Sparkling or fluxation Before attaching the spherical glass electrode to the patient place one fingertip on the extremity of the pen and only remove it when the electrode is in contact with the patient s ekim E 23 Figure 4 Fork glass electrode used in direct sparkling or fluxation in curved treatment areas such as neck arms breasts armpits EC ask NNN NN NNN NNN unn E ee 23 Figure 5 Saturator glass electrode used in indirect sparkling It increases the vascularization of the skin It is normally applied with oils and skin nutrition Creams 23 Figure 6 Correct position for the patient to hold the Saturator glass electrode while the therapist performs manual stimulation on the treatment area 24 Figure 7 Cauterizing glass electrode used in direct sparkling for acnebemostaele erra 24 SYMBOL DEFINITIONS BELOW ARE THE DEFINITIONS OF THE SYMBOLS USED ON THE EQUIPMENT AND THROUGHOUT THE INSTRUCTIONS FOUND IN THIS MANUAL UNDERSTAND THESE SYMBOLS AND THEIR DEFINITIONS BEFORE OPERATING THIS EQUIPMENT A Caution Refer to user manual an Keep away from the rain Voltage in AC Alternating Current Ka Stacking up Fragile This side up ae Limits of temperature for storage and X packa
16. ging in C Celsius Degrees PREFACE These instructions of use allow the user to use the Ibramed HF Pen efficiently Users must read understand and fol low the information present in these instructions of use for each possible treatment mode as well as indications contraindications warnings and precautions The speci fications and instructions present in these instructions of use are applicable on the date of its publication These in structions of use can be visualized at any given time under the manufacturer criterion Visit our webpage for updates PRODUCT DESCRIPTION HF Ibramed is a portable high frequency piece of equipment for facial body capillary and podology application The application frequency is monopolar that is only one electrode is used The function of the gas inside the electrode is to induce the current flow This gas is excited through the passage of electric current and produces a light whose color depends on the type of gas used The gas is then onized by the high tension making the glass bulb fluorescent e Position the HF Pen cable in such a way that it is free away from places where it might be treated on and do not place any piece of furniture over it e The HF application electrodes are made of glass Incorrect handling may break them or affect their characteristics IT Tr Therefore avoid impact or mechanical chocks e Do not introduce object in the orifices on the equipme
17. les and moving parts power cords connecting cables to the patient Company authorization of operation 103 603 1 conductive rubber electrodes glass electrodes tips pen body holders and cabinets of the equipment Technician in Charge Maicon Stringhetta 7 No sales representative is authorized to change the CREA SP 5062850975 conditions mentioned or commitments on behalf of IBRAMED 29 CEFAI IBRAMED CENTER FOR EDUCATION AND ADVANCED TRAINING IBRAMED Equipment goes beyond technology It also Special attention is also given to those interested in visiting provides knowledge Science constitutes our differential our structure Whatever your professional development value and we effectively take advantage of its benefits needs we ll be right by your side to provide you with in order to ensure patient safety and thereby maximize unconditional support results We are happy to assist you IBRAMED develops products with scientific support of the most recent medical studies published in major scientific Contact cefaiQconexaocefai com br journals in the areas of biological health and exact www conexaocefai com br 55 19 3808 2348 Access to the knowledge database is guaranteed by CEFAI IBRAMED Center for Education and Advanced Training Thanks whose goal is to provide technical and scientific support as well as current literature on therapies and their applicability while our treatment choices are always thoroughly selected ac
18. nd of the safety equipment only in cases where the unit was used according to the instructions for use contained in the manual where maintenance repairs and modifications have been made by the factory or authorized agents and where the components that can cause security risks and the appliance has been replaced in the event of a breakdown by original the spare parts If requested IBRAMED can make the technical documentation circuit diagrams lists of parts and components etc necessary for the repair of any equipment We assume no responsability for the repairs without our explicit written permission WARRANTY IBRAMED Ind stria Brasileira de Equipamentos M dicos Ltda here identified to consumers by the phone and address 2800 Dr Carlos Burgos Ave Jd It lia CEP 13 901 080 Amparo SP phone 55 19 3817 9633 warranties this product for a period of eighteen 18 months under the terms of the warranty below 26 WARRANTY TERMS 1 IBRAMED product is warranted against defects in man ufacturing if considered the established conditions by this manual for 18 consecutive months 2 The warranty period shall start from the date of purchase of the first owner even if the product is transferred to third parties It will involve the replacement of parts and repairing of the defects when certified that the problems have occurred 3 The warranty service shall be exclusively made by the sales center representing IBRAMED by IBRAM
19. nt and do not lean any recipients containing liquid on the equipment e Do not use volatile substances benzene alcohol and solvents in general to clean the Ibramed HF Application Pen They may damage the equipment cover Use only a clean dry and soft cloth T SAFETY PRECAUTIONS PRECAUTIONARY DEFINITIONS The precautionary instructions found in this section and throughout this manual are indicated by specific symbols Understand these symbols and their definitions before operating this equipment prior to therapy session AX CAUTION Text with a CAUTION indicator refers to potential safety infractions that could cause minor to moderate injury or damage to equipment AN WARNING Text with a WARNING indicator refers to potential safety infractions that could cause serious injury and equipment N DANGER Text with a DANGER indicator refers to potential safety damage infractions that represent immediately life threatening situations that would result in death or serious injury e Read understand and practice the precautionary and operating instructions Know the limitations and hazards associated with the use of any electrical stimulation e Observe the precautionary and operational labels placed on the unit e DO NOT operate this unit in an environment where other devices intentionally radiate electromagnetic energy in an unshielded manner This unit should be transported an
20. properly licensed use and operation of the equipment IBRAMED makes no representations regarding laws and federal state or local laws that may apply to the use and operation of any electromedical equipment The physician or under his command also the physical therapist or other professional health care licensed assumes total and full commitment to contact the local certifying agencies to determine any credential required by law for clinical use and operation of this equipment The use of electromedical equipment must comply with the local state and federal country 10 ENVIRONMENTAL PROTECTION HF IBRAMED is an electronic device and has heavy metal parts such as lead So there are risks of contamination to the environment associated with the discharge of this device and its accessories at the end of their service life HF IBRAMED its parts and the accessories must not be disposed of as urban residues Contact the local distributor to obtain information about norms and laws relative to the elimination of electrical residues electronic equipment and their accessories A CAUTION The device and its consumable parts must be eliminated at the end of their shelf life according to the federal norms and or state norms and or local norms of each country 11 ELECTROMAGNETIC COMPATIBILITY GUIDANCE Medical Electrical Devices require special attention regarding Electromagnetic Compatibility EMC and must be installed and put into
21. r High Frequency 03026018 Large Spherical electrode for High Frequency 03040004 IBRAMED Digital User s Manual 260410 03026038 Case for Portable HF Ibramed 26 TROUBLESHOOTING What may initially look like a problem is rarely a defect Before calling customer support please check the items described below PROBLEMS SOLUTIONS The equipment does e Is the power cable properly connected not turn on 1 If not connect it Also check the wall socket The equipment is turned on but does not emit current to e Have you followed the recommendations for correct use the equipment as mentioned in the instructions patient 1 Check and repeat the steps in the controllers indications and operation section The equipment is e Have you checked the electrodes and the connecting cables to the patient turned on but does Check if the cable plug is adequately inserted in the equipment lane Mi egrrent EG Check if the electrodes are adequately placed on the patient s body The equipment does e Is the 110 220v switch key correctly adjusted for the local net not turn on and or work properly Check and if necessary adjust this key properly 27 MAINTENANCE WARRANTY TERMS AND TECHNICAL SUPPORT MAINTENANCE We suggest that you make an inspection and preventive maintenance at IBRAMED or authorized technical center allowed every 12 months for use of equipment As a manufacturer IBRAMED is liable for the technical features a
22. r transmitters with a maximum nominal output potency not listed above the separation distance recommended in meters m may be determined by an equation applicable to the frequency of the transmitter where P is the maximum nominal output potency in watts W according to the manufacturer of the transmitter NOTE 1 From 80 MHz to 800 MHz the distance of separation relative to the highest frequency band is applied NOTE 2 These directions may not be applicable in all situations The electromagnetic propagation is affected by the absorption and reflection of structures objects and people NOMENCLATURE 1 HF application pen High Frequency intensity on off switch HF pen cable Power feeding equipment HF cable output 110 220 volts converter key E Connection pins from feeding source to power outlet 19 SPECIFICATIONS SYSTEM SPECIFICATIONS Dimensions Temperature Range During Transport and Storage Width 7 cm 2 7 in 5 50 C 41 IA Depth 11 cm 4 3 in Environment operating temperature range Height 6 cm 2 3 in 5 45 C 41 113 F Standard Weight without accessories 500 g Power Input 127 240V 50 60 Hz Input Power 50 VA Electrical Class CLASS II Electrotherapy TYPE BF Regulatory Compliance IEC 60601 1 IEC 60601 1 2 20 HF IBRAMED ELECTRICAL POWER FEED HF Ibramed is adjusted for a power grid of 220 volts 50 60 Hz If necessary it can be adjusted for 110 volts 50 6
23. zation of skin following pustule extraction e Allergy to current e Facilitation in permeation of an active e Infection processes e Skin rejuvenation and hydration protocols e Epilepsy e Disinfection of scalp in case of seborrhea e Kidney or cardiac insufficiency e Facial and capillary blood circulation stimulation e Patients with diagnosis for deep venous thrombosis e Post depilation e Solution of skin continuity ulcers of pressure and open wounds e Sore wounds following extraction of nail bed cuticle N WARNING GENERAL CONTRAINDICATIONS e Do not use as an adjuvant flammable or alcoholic nature e Pregnancy or intention to become pregnant products e IMPLANTED ELECTRONIC DEVICES We recommend e Remove all metal accessories of the patient that a patient with an implanted electronic device ex pacemaker is not subjected to electrostimulation therapy unless a medical authorization has been previously given e HEARING AIDES hearing aides must be removed during sessions If subjected to electrical stimulation the hearing aides might undergo damage and present malfunction PATIENT PROFILE USERS PROFILE AND TREATMENT AREA PATIENT PROFILE e Patients must be over twelve years of age under that age only by medical or physiotherapeutic prescription e Patients must weigh more than 35 kg under that weight only by medical or physiotherapeutic prescription e There are no restrictions regarding nationality e Patients
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