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1. PRONEXIBUS is guaranteed for 24 months only in case the warranty labels attached in factory remain untouched ESSENTIAL CONDITION FOR MAINTAINING THE WARRANTY AND COMMISSIONING See warranty section of this document Before operating with PRONEXIBUS make sure that the annual electronic check up has been made and from the date of the last calibration no more than 12 months has been passed c Disinfection of handpieces and of related screwed plates and discoids The handpieces and plates discoids must be cleaned and disinfected before and after each use Handpieces plates and discoids can be cleaned by normal disinfectants However avoid use under water of Acetone Nitro diluents Trichlorethylene benzine Any kind of acids and anyway in case of PH below 6 Basic components with PH above 8 We recommend the use of the following sterilizing products FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 22 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual appropriately diluted alcohol disinfectant and antifungal preparations Products diluted with hypochlorite Hydrogen peroxide at low medium volume DO NOT STERILIZE AT HIGH TEMPERATURES d Daily check up PRONEXIBUS must undergo a check
2. 80MHz RF Radiated EN 61000 4 3 3 Veff from 80MHz to 2 5GHz 3 Veff from 80MHz to 2 5GHz Mobile and portable RF communication devices should not be used nearby PRONEXIBUS including the device itself and its accessories and cables except in cases they respect the recommended separation distances calculated from the equation applicable to the transmitter s frequency Recommended separation distances d 1 2 yP from 150kHz to 80MHz d 1 2 VP from 80 MHz to 800 MHz d 2 3 VP from 800 MHz to 2 5 GHz where P is for maximum nominal output power in Watts W declared by the manufacturer and d is for recommended separation distance in meters m Field intensity from fixed RF transmitters as determined by an electromagnetic site survey may be less than the conformity level in each frequency range Interference may present near equipment marked with the following symbol o FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Recommended separation distances between PRONEXIBUS and mobile and portable radio communication devices PRONEXIBUS is designed to operate in an electromagnetic environment where radiated
3. Pg 11 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Instructions for use a Environment requirements for the use PRONEXIBUS can be used in any environment corresponding to the standards defined by the current legislation regarding the electrical systems and sanitary authorizations The device was designed and certified for home use but treatments must always be done by physicians physiotherapists or nursing personnel under medical supervision Patients must not use independently the device In order to avoid any kind of interferences do not use PRONEXIBUS on the patient simultaneously with other electromedical devices Do not use PRONEXIBUS in surgical environment or _ near life support equipment Critical Care it may cause interferences b Pre and post treatment indications It is not necessary to follow specific protocols or particular precautions before the treatment Normally the patient once concluded the therapy can get back to his normal daily activities Anyhow it will be the physician to decide and give the necessary indications thereupon It is not required to take any post treatment precautions Anyhow it will be the physiotherapist or the physician to decide and give the necessary indications thereupon In case physician would use the handpiece in a dynamic way i
4. s Manual In the lower compartment of the suitcase you can find the high frequency generator to which the above mentioned accessories must be connected The power switch is to be placed into the socket in the upper right Connect the power cord to the dedicated socket of the generator lower case of suitcase Make sure that ON OFF switch is positioned OFF Atthis point connect the 10 Amp plug to the wall jack Place the chair or bed where the patient will have to sit or lie down close to PRONEXIBUS Place the isolating mat on the chair or bed and connect it using the right cable the one with banana termination to PRONEXIBUS on th top of the generator Connect the free connector of the chosen handpiece to the plug of the generator screwing it carefully At this point switch on Pronexibus and verify that the green ON Led near the input jack is lightning FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 14 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual PICTURE 2 Verify that the display shows the following figure pic 3 d Description of displays of the touch screen PRONEXIBUS has one display allowing the operator to select the operating and emitt
5. equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual IN CASE OF ANY KIND OF MALFUNCTION f e problems in setup missing power emission too low power emission LED faults STOP IMMEDIATELY THE TREATMENT SWITCH OFF THE DEVICE DISCONNECT IT FROM THE PLUG AND CALL THE ASSISTANCE FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 21 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Maintenance a Generalities PRONEXIBUS as it was designed and built requires 1 Annual check up of the output power parameters by specialized technicians 2 Disinfection of the handpiece s plates discoids 3 Daily check up of cables and accessories 4 PRONEXIBUS therefore plates and discoids MUST NOT be used on skin wounds injured skin in general eyelids or eyes b Annual check up PRONEXIBUS being an electronic instrument must be submitted to an annual test to verify the calibration of power parameters at different levels of emission and the right functionality of safety checks Calibrations and verifies must be performed by authorized personnel in possess of measuring and test equipment suitable for this purpose
6. up every day and each time you may open the suitcase container making sure to check also the conditions of the connecting cables e Handpieces PRONEXIBUS must undergo a check up every day and each time you may open the suitcase container Pay attention to the condition of the coating surface of the discoid Check colour and quality in case of doubts replace the plate with a new one see paragraph dedicated to the handpiece Check the attachment of the handpiece you intend to use and its connection to the blocking mat that must be placed under the patient The blocking mat does not require a skin contact with the patient nor use of gels or conductive creams FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 23 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Warranty PRONEXIBUS being a generator suitcase has a warranty of 24 months only in case that if controlled the warranty labels attached in fabric result untouched ESSENTIAL CONDITION In case of any kind of tampering PRONEXIBUS or its components and or accessories the warranty will be void and the device can not be put in service anymore Handpieces have a warranty of 12 months Discoids plates have a warranty of 6 mo
7. void and the medical device can not be put into service e Install the device in a place with good air circulation Do not block the vent slots on the device e Do not place in any case glasses bottles cosmetic products gels or any kind of containers of various products etc over the inner cover of the device e Do not pull the cables e Do not press the touch screen e In case the medical device does not emit signals or a malfunction is present switch off immediately PRONEXIBUS remove the power and contact the technical support Warning PRONEXIBUS emits through the handpiece controlled _high frequency electromagnetic _fields which in case of direct contact with the patient are Closed by the insulating mat This must be connected to the bushing of PRONEXIBUS _and be positioned under the patient no_skin contact or use of creams or conductor gels are required In case of direct contact with the patient for hygienic_and sanitary reasons it is advised the isolation with a cloth or a tissue PRONEXIBUS may interfere with other medical equipments Do not use PRONEXIBUS in surgical environment or near _ life support equipment Critical Care In case treatment would occur at the home of the patient and the device would interfere with appliances such as sufficient to interrupt treatment and change room Possibly switch off the device before restarting the treatment Pay also attention to the indications on the display of the dev
8. 93 42 and CE 07 47 being intended to supply energy to the human body in a non potentially hazardous way taking in consideration the nature the density and the place where the energy is applied Rule 09 Annex 09 Directive 93 42 CE Regarding home use we highlight that the device is not a B classed This fact however is an acceptable limitation in accordance to the benefits both from a health therapeutic point of view and for the collective economy Disorders due to eventual interferences with home appliances in case of home use are absolutely not dangerous neither for the patient and nor for the operator and cause no damage to the appliances Discoids must be properly cleaned and disinfected before and after each application WARNING DO NOT use the medical device near children they could get hurt or damage the device Pay special attention to the handling of cables for the risk of strangulation WARNING KEEP THE DEVICE AWAY FROM CHILDREN WARNING Always lock the suitcase after use in order to avoid the use of the device by unauthorized persons or children Pay attention in handling the cables risk of strangulation IN CASE OF ANY KIND OF ANOMALIES f e problems with set up no energy supply low energy supply led off INTERRUPT THERAPY SWITCH OFF DEVICE AND CALL ASSISTANCE FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014
9. RF disturbances are under control The client or the operator by maintaining the minimum recommended distance between PRONEXIBUS and other mobile and portable RF equipment can contribute to prevent electromagnetic interferences in relation with the maximum output power of radio communication devices For the minimum recommended distances see the chart below The transmitter s Separation distance to the transmitter s frequency m KERTU Mc From 150kHz to From 80MHz to From 800MHz to 2GHz ad has 80MHz 800MHz d 2 3 VP d 1 2 vP d 1 2 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 In case of transmitters with a nominated maximum output power not listed above the recommended separation distance in meters can be calculated using the equation applicable to the transmitter s frequency where P is for maximum nominal output power in watts W declared by the manufacturer Note 1 At 80 MHz and 800 MHz the range to apply is that of the higher frequency 2 These guidelines may not be applied in all circumstances Electromagnetic propagation is influenced by the absorption and reflection of various structures objects and persons FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it
10. Rev 04 of 28 08 2014 Pg 1 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual User s Manual Instructions for the use and maintenance of Medical Equipment PRONEXIBUS FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 2 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual INDICE Introduction Safety information General information Contents of the packaging Technical specifications Regulations Instructions for use a Environment requirements for the use b Pre and post treatment indications c Switching comands and indications d Description of displays of the touch screen e Choice of the handpiece f Treatment parameters g Antalgic and physiotherapies h Contraindications a Generalities b Annual check up c Disinfection of the handpieces and of related screwed plates and discoids d Daily check up e Handpieces FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 3 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pa
11. aiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 16 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual of the handpiece and of the frequencies number of needed treatments WARNING In case the erogated energy should result excessive the patient could feel a light burn In this case remove immediately the discoid of the handpiece from the patient s skin place the handpiece on a flat surface and press the START button which becomes button PAUSE colour yellow At this point recalibrate the power and get back to work pressing the yellow PAUSE button It is always recommended that you start the treatment under the threshold of 50 of the power paying always attention to what the patient perceives An average treatment should last around 20 minutes anyhow it is recommended not to exceed 40 minutes per treatment session The duration of the treatment will be always determined by the physician or physiotherapist based on the width of the area to treat the pathology and the patient In case of degenerative diseases it is recommended to treat the patient once in 72 120 hours each 3 5 days while in case of traumatic diseases treatments could be run once in even 24 or 48 hours However it will be up to the your physician to decid
12. at the User s Manual contains FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 4 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual important information regarding safety Ke This symbol warns the user that the device emits radio frequency but does not emit ionizing radiation 1 aig This symbol warns the user to store and use medical device in a dry place away from water C g 0476 This symbol refers to the certification obtained for the medical device according to directives CE 93 42 and CEE 07 47 by CERMET This symbol indicates applied parts of the medical device as type BF floating I n addition to the normal safe recautions please take out the following steps to protect your and the patient s safety and that of the product and its accessories Do not overload the socket by plugging double or triple plugs or multi sockets This medical device needs to be connected by one single wall outlet e Do not use not protected power outlets it can be dangerous e Always control that electrical connections are correct there should not be any exposed wires In case you are invited to contact a qualified technician e Make sure that the wall socket has the right ground connection
13. e for the frequency the power the number and duration of the single cycles to adopt and for the number of treatments to run g Antalgic and physiotherapies PRONEXIBUS can be used with extreme efficacy for the treatment of pain caused by a wide range of diseases We remind you to the extraordinary anti inflammatory and anti oedema effect Therefore among many others you can treat Joint distortions muscle strains spasms contusions inflammations etc h Contraindications The application of the electric currents is absolutely contraindicated in cases of e Pace maker e Cancer e Pregnancy e Presence of brain stimulating electrodes Some of the above mentioned contraindications make part of the list for not having available case studies in relation FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 17 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual i Protection measures The treatment cycle can not begin in the following cases The handpiece s connecting cable is unplugged Start button on touch screen is not pressed The treatment cycle begins but with power educed to minimum In case the mat is not connected properly by an appropriate cable to the socket of the device loca
14. e positioned within the filtered socket as indicated by the front screen printing In case of any malfunction contact immediately the technical support FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 7 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual General information PRONEXIBUS is a therapeutic type medical device that by the application of low power and high frequency via two types of handpieces causes the stimulation of connective and muscle tissues as well as having an anti inflammatory and anti oedema effect There is the possibility to select three types of high frequency LF of 2 Mhz MF of 4 Mhz HF of 8 Mhz Besides this there is the possibility to select the power the number of cycles timings and sound volume Contents of the packaging Suitcase with the medical device User s manual Safety test sheet The upper compartment of the suitcase contains n 1 handpiece with head plate discoid with application diameter of 40 mm n 1 handpiece with head plate discoid with application diameter of 50 mm n 1 power cord with plug of 10 Amp and ground socket n 1 cable with two banana terminations to connect the suitcase with the isolating mat t
15. ect and constant contact with the skin area to treat When the handpiece is in movement and comes lifted or disconnected from the skin Pronexibus reduces immediately the output power and reinitiates ther always starting from the half of the power set previously The emitted power arrives to the requested level in some seconds 13 At the end of each cycle PRONEXIBUS emits a beep sound and in case more cycles were set up previously restarts FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 19 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual 14 For each cycle the maximum emission time is 30 minutes that can be repeated max 20 times max number of cycles that results max 10 hours of power emission and treatment 15 To interrupt a treatment cycle remove the handpiece s plate discoid from the skin and place it on a flat surface At this point pressing START button the emission is interrupted and you can change the setting of the parameters duration number of cycles power use of handpiece Press START again that in the meantime became yellow with PAUSE written on and the treatment will restart from where it was blocked Contrary as above described pressing STOP during a treat
16. gt 95 gap of Ur for 5 seconds lt 5 UT gt 95 gap of Ur for 0 5 cycle 40 Ur 60 gap of Ur for 5 cycles 70 UT 30 gap of Ur for 25 cycles lt 5 Ut gt 95 gap of Ur for 5 seconds Quality of grid voltage should be that of anormal commercial or hospital environment If user requires continued operation even during the interruption of grid voltage it is recommended to supply the equipment with an Uninterruptible Power Supply UPS or battery Magnetic field to the mains frequency EN 61000 4 8 3 A m 3 A m Magnetic fields at grid frequency should have the same characteristics as a normal commercial or hospital environment FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 26 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Immunity aspects a r f PRONEXIBUS device is designed to operate in the below specified electromagnetic environment Client or operator should make sure that the device is used in these circumstances Immunity test Test level EN 60601 1 2 Conformity level Electromagnetic environment guidelines RF Behaviour EN 61000 4 6 3 Veff from 150kHz to 80MHz 3 Veff from 150kHz to
17. hat blocks the return currents n 1 Isolating mat that allows to block the return of high frequency currents FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 8 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Technical specifications 1 Joule the symbol J is the measurement unit of energy and coincides with Watt per second J W s N m K m s2 Parameters Values Commercial denomination ProNexibus Aims and function of use High frequency device 2 4 8 MHz from 8 J cm2 max Physioterapic and antalgic therapies Weight lt 10 5 Kg Power supply From single phase system 110 220 V 10 50 60 Hz by a plug with protective conductor and no voltage change Connectorised cable IEC detachable by plug socket Power absorbed by the net 250 VA max Output power 100 Joule max Frequencies LF 2 MHz MF 4 MHz HF 8 MHz Environmental condition requirements Temperature 10 35 C Relative humidity 30 85 FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 9 27 High freq
18. ice and on the following label inside the cover FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 6 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual FOCUSMED SRL Largo Traiano 4 Montegrotto Terme PD Tel 389 0666696 In case of treatment at the patient s home healthcare professional must verify that the electrical system of the location possesses regular conformity certifications required by law and is regularly tested by qualified personnel In case of unsuitable circumstances the treatment MUST NOT be performed The use of PRONEXIBUS is dedicated to physicians physiotherapists and nurses always under medical supervision PRONEXIBUS can not be used independently by the patient PRONEXIBUS can be used in any environment with an electrical system in accordance with current legislation and in possess of required authorizations The device is designed and certified also for home use Keep the medical device away from children and always close it with the appropriate supplied keys Attention to cables Danger of strangulation Do not use the medical device in explosive environment and or areas saturated with oxygen f e hyperbaric chambers The fuses are of 2 5 Ampere and ar
19. in management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Introduction This document provides information for the implementation and for the correct use of Pronexibus medical device This document is an essential guide for the user before the installation and use of the medical device it is essential to read the Manual carefully and to keep it always handy for a quick reference The non compliance even if partial of all that is contained in the Manual may lead to malfunctions damages to the medical device and invalidation of the warranty Safety information 1 To reduce the risk of fire or electric shock do not expose the medical device to rain or to a relative humidity that exceeds 85 with condensation Make sure before use that these conditions are not present In case of these conditions would be present it is recommended not to open the suitcase that contains the medical device and consequently not switching it on WARNING to reduce the risk of fire or electric shock do not remove the panel of the device In case of problems please contact exclusively the qualified service personnel of Focusmed srl AN The lightning symbol within an equilateral triangle alerts the user of dangerous voltage inside the medical device and danger of electric shock ELECTRICAL SCHOCK HAZARD This writing reminds the user the importance of the previous symbol N This symbol reminds the user th
20. ing mode of the device The display is touch screen type and by wep buttons allows Select the operating frequency LF MF HF ct the output power shown in W corresponding to 1 second for 1 PICTURE 3 FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 15 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual e Choice of the handpiece As already mentioned PRONEXIBUS has two handpieces that differ only by the dimensions of the application of the plates with diameters of 40 mm or 50 mm or 30 and 60 mm eventually We note that equal emitted power is distributed on the two different surfaces In case of application of the 40 mm discoid the operating power will be slightly less than twice of the operating power with the application of the 50 mm diameter discoid The two discoids are screwed on the handpiece After use we recommend to store it as soon as possible in the cover s foam insert Handle carefully do not hit it so it does not lose the isolation needed for the proper use The white colour of the glaze on the surface allows its easy inspection If you note scratches or the colour may not be pure white anymore change the application plate In case of the transmission plate of the handpiece would da
21. mage and or have scratches it must be changed immediately particularly for the safety of the patient in treatment The handpiece can be slid on the skin of the patient or kept stationary it will be the physician to decide In order to make the discoid slide easier on the patient s skin you can use neutral skin creams The handpiece is to be chosen by the dimensions of the area to treat by the energy that should be dispensed power and by the pathology to treat f Treatment parameters As fundamental guideline for the choice of treatment parameters the patient s sensational feedbacks must be taken in consideration In order to optimize the results of the treatment it is particularly important that the patient must feel a nice warmth during each cycle treatment but not reaching the limit of tolerance The sensation of the heat experienced by the patient should be slight and never excessive It is also very important to take in consideration that the sensitivity to pain and or heat could be different from patient to patient Therefore the sensation referred by the patients during the treatment can show also significant differences even in case of identical treatment parameters It will be always the physician or physiotherapist to decide for the parameters to adopt after a precise evaluation based on the pathology the patient and the body area to treat setting the power duration number of cycles choice FOCUSMED S r l Largo Tr
22. ment will reset all settings you will have to set each parameter and cycles will start as for a new treatment 16 The use of any gel or conductive cream is not required neither for the plate discoid neither for the blocking mat To facilitate the sliding of the handpiece you can use a neutral cream on the patient s skin 17 The choice of the handpiece is made by the physician after evaluating the width of the area to treat the pathology and the power to be dispensed K Precaution for Use PRONEXIBUS uses controlled high frequency currents that are blocked by the mat therefore patient must be seated or lied down on such blocking mat The blocking mat is connected to the device by the required cable in the appropriate socket placed in the bottom right In lack of clinical studies at disposal avoid the use of the device in the following cases a Pregnancy b Patients with heart diseases with cardiac stimulator applied f e pacemaker IMPORTANT Do not use PRONEXIBUS in case of patients with AIMD Active Implantable Medical Devices pacemaker hearing aids electrodes for cerebral stimulation etc PRONEXIBUS therefore discoids and plates must not be used on skin wounds or injured skin in general nor on eyelids or eyes FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 20 27 High frequency e low potency medical
23. nths The blocking mat and its connecting cable have a warranty of 6 months Warranty covers only manufacturing defects and do not cover damages or malfunctions from wear or heavy or abnormal use transport or storage Disposal PRONEXIBUS compatibly with operating and safety requirements have been designed and constructed to minimize the negative impact on the environment The criteria were the minimization of waste toxic materials noise undesired radiation and Energy consumption A careful study on how to optimize yield of the devices can result reduced consumption in harmony with the concepts of energy savings ys This symbol indicates that the product should not be disposed with other domestic waste The user must dispose of the device by handing it over to a specific collection centre for the recycling of electrical and electronic equipment In case of problems please contact us FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 24 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Annex 1 EMC charts PRONEXIBUS was designed and constructed in accordance with the standards regarding electromagnetic compatibility CE certification proves conformity also regarding this aspect As fo
24. o banana terminations to the socket placed right in bottom of PRONEXIBUS the bush side is positioned in the lower right corner of PRONEXIBUS while the pipette blue is located on the blocking mat 7 Make sure that the chosen handpiece is linked to the appropriate connector the device reports on touch screen in the STATO section and that it is well fixed 8 Press Start button on touch screen and verify that the red LED Tx on the cover of the suitcase is on near the green Led ON ee 9 Place the plate f the handpiece on the skin area to treat and make sure that the FWD signal is going slowly towards the maximum depending on the power set the sigwal will stop at the set point for example in case of 50 of the power the signal will stop in the white area ca at the half while the RL signal should descend towards the minimum closer the signal is to the minimum moke the patients absorbs the energy 10 The power is supplied from the minimum available and is set afterwards according to the adjustments 11 In case of any kind of anomalies during the absorption of the emitted controlled high frequencies PRONEXIBUS ensures an automatic reduction of the power in order to avoid any injuries to patient or to the operator 12 During the treatment in order to obtain a constant delivery of the high frequencies keep the entire surface of the plate of the handpiece the white plate discoid area of the handpiece in dir
25. r its operating method PRONEXIBUS generates a certain quantity of controlled high frequency energy and has got an appropriate level of immunity to radiating electromagnetic fields EMF In order to not to alter the electromagnetic behaviour of the device operator must not modify in any way the device itself and or its accessories and or any cables In order to avoid harmful interferences to radioelectric communications to other medical equipment used for monitoring surgery or any kind of therapies to any electronic equipment such as office computers printers copiers faxes etc or to any kind of electric or electronic equipment used near to PRONEXIBUS considering the characteristics of electromagnetic compatibility see the following chart in accordance with EN 60601 1 2 Emission aspects Emission test Conformity Electromagnetic environment guidelines a Class A group 2 PRONEXIBUS emits electromagnetic Emission RF energy to fulfil its therapeutic functions CISPR 11 Equipment near might be influenced by the produced magnetic fields Harmonic emissions Class A It is possible to use PRONEXIBUS in any IEC 61000 3 2 Complies kind of buildings including residential and those directly connected to the low voltage public power supply network Fluctuating emissions Complies of voltage flicker IEC 61000 3 3 FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www foc
26. t may cause redness caused by the rubbing The redness should disappear within an hour FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 12 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual c Switching commands and indications In the suitcase container PRONEXIBUS are stored the controlled high frequency generator and the related and necessary accessories for the proper use In the upper compartment of the suitcase you can find see pic 1 n 1 handpiece with head piaster discoid with application diameter of 40 mm n 1 handpiece with head piaster discoid with application diameter of 50 mm n 1 power cable wit a 10 Amp plug and ground socket n 1 cable with two banana terminations to connect the suitcase with the isolating mat that blacks returningxcurrents n 1 isolating mat allowing to block the returning high frequency currents PICTURE 1 FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 13 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User
27. ted in the right bottom corner In case the mat is not positioned below the patient s body In case the plate discoid of the handpiece is not in direct contact with the patient s skin The treatment cycle is suspended under the following conditions If delivery circuits of output power would be out of control If absorption of the power terminals exceed the maximum permissible current If the plug of the handpiece should disconnect IN CASE OF ANY KIND OF MALFUNCTION STOP IMMEDIATELY THE TREATMENT SWITCH OFF THE DEVICE UNPLUG POWER AND CALL FOR QUALIFIED ASSISTANCE I Use 1 Set the emission power by the special symbols on the touch screen BIES e N EG SINTO NAQL N ES D N QO D J lect the emission frequency from the 3 available pis the necessary duratjon for the treatment by the appropriate symbols on the touch screen 4 By pressing the appropriate signals turn on or turn off the acoustic transmission signal afd adjust its volume 5 Set the number of emission cycles FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 18 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual 6 Place the blocking mat under the patient there is no need of skin contact and connect the mat by the cable with tw
28. that must be controlled according to current standards e Do not use electrical outlets near water containers swimming pools bathtubs showers washing machines sinks etc e Do not place the equipment over unstable objects this can cause serious injury or damage to the equipment e Do not place the device near stoves heaters furnaces fans audio amplifiers and or TV this can cause malfunctions e Always disconnect the appliance from the electrical outlet before cleaning e Do not try to insert the current plug in old type plugs or forcing it In case contact a qualified electrician FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 5 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual e Do not step on or place any kind of objects on the power cord In case the cord is ruined replace it with a new one e Disconnect the device from the wall outlet in case of storms or long absence e Do not attempt to open the system and do not touch the contained components These operations can be done only by qualified and trained personnel for the maintenance repair e Do not tamper PRONEXIBUS medical device In case the device should be opened and or tampered with by unauthorized staff the warranty should be
29. uency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Atmospheric pressure 70 106 kPa Storage and transport conditions Temperature 25 70 C Relative humidity 10 100 condensation included Atmospheric pressure 50 106 kPa No handpieces 2 Emission mode Continuous 100 Joule max on 100 Ohm Reflected power control 15 Joule max Maximum effective intensity in case of normal use and first malfunction 14 2 J cm q on handpiece of 30 mm 8 J cm q on handpiece of 40 mm 5 J cm q on handpiece of 50 mm 3 5 J cm q on handpiece of 60 mm Time for each emission cycle no Max cycles 1 30 min 20 cycles Safety class a I type BF CEI EN 60601 1 CEI EN 60601 2 3 Internal power source 48V 4 A e 24 V 3 amp Fuse value 2 5 Amp re Level of protection for the medical device IP20 FOCUSMED S r l Largo Traiano n 4 Montegrotto Terme PD P IVA 04590310282 www focusmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 10 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Regulations Active therapeutical device class I and type BF class IIb according to CEE
30. usmed it e mail admin focusmed it Rev 04 of 28 08 2014 Pg 257 27 High frequency e low potency medical equipment for physiotherapy rehabilitation and pain management Model PRONEXIBUS Patent Application n PD2011A000318 User s Manual Immunity aspects PRONEXIBUS device is designed to operate in the below specified electromagnetic environment Client or operator should make sure that the device is used in these circumstances Immunity test Test level EN 60601 1 2 Conformity level Electromagnetic environment guidelines Electrostatic discharge ESD EN 61000 4 2 6kV at contact 8kV in air 6kV at contact 8kV in air Floor surfaces should be made of wood concrete or ceramic tile In case the floor surface is covered by synthetic material relative humidity must be at least of 30 Transitors fast electric trains EN 61000 4 4 2kV Power supply lines 2kV Power supply lines Quality of grid voltage should be that of anormal commercial or hospital environment Impulses EN 61000 4 5 1kV Differential mode 1kV Differential mode Quality of grid voltage should be that of anormal commercial or hospital environment Voltage gaps short interruptions voltage variations on input lines EN 61000 4 11 lt 5 Ut gt 95 gap of Ur for 0 5 cycle 40 Ur 60 gap of Ur for 5 cycles 70 UT 30 gap of Ur for 25 cycles lt 5 UT

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