bruxoff - OT Bioelettronica
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1. User s Manual bruxoff The Holter for the monitoring of Bruxism bux User Manual Spes Medica S r l SDES medica pau AAA the med ical accessories source Spes Medica s r l Via Europa Zona Industriale 84091 Battipaglia Sa tel 39 0828 614191 fax 39 0828 331788 www spesmedica com info spesmedica com A N Read this manual carefully before using Bruxoff C 0476 This product is manufactured in compliance with the CE European Medical Device Directive and later directives and additions 2007 47 directive and according to the reference norms CEI EN 60601 1 60601 1 2 60601 1 11 60601 2 40 60601 1 6 CEI IEC 62304 Directive 2002 96 CEE v1 1 Ed 02 2012 Pag 2 28 brux User Manual Spes Medica S r l SYMBOLS USED The graphic symbols used on this device and on this manual refer to the UNI EN ISO 980 Law CEI EN 60601 1 RAEE Law and 2002 96 ECC Directive Device with BF parts fo Class II device Warning read the instructions before using the device This symbol could also be used as a Warning symbol Read the instructions of use i Merutctrer Do not dispose this product as unsorted municipal waste Collection of such waste separately for special treatment is necessary following the 2002 96 EC Law of the European Parliament and Council of the European Union about the disposal of e waste The Bruxoff device has been tested in reference to the EN 60601 1 and the EN 602. l 5 THE USER USER Patient a Age gt 15 years old b C d e Patient status able to understand the use of Bruxoff with Bruxism problems N Weight not important Health no heart problems or pacemakers Sr NS NAN Nationality not important Education level High school Knowledge Minimum Basic notions about the human body Languages Italian and or English Experience Minimum Minimum training about the device use Handicaps maximum reduction of the hearing of 40 with residual hearing at 60 maximum sight reduction of 40 with residual sight at 60 5 SAFETY CAUTIONS AND WARNINGS The use of Bruxoff is forbidden in the following conditions e Simultaneous use of electro surgery systems shortwave or microwave therapy or near these type of devices e Unsound mind patient e the device is damaged e Near inflammable anaesthetics with air oxygen or nitrous oxide e To make an electrocardiographic exam e Pacemaker users These warnings must be followed e Contact immediately the manufacturer if foreign materials liquids etc come into contact with the device e lf the device falls in to the ground or something similar happens check that the device is undamaged In case of doubt contact the manufacturer v1 1 Ed 02 2012 Pag 6 28 GrUxe User Manual Spes Medica S r l The Bruxoff device could be sensitive to electromagnetic interferences of other devices that could alter its electr
3. saved with the date 1 1 2012 and time 01 00 etc Order the v1 1 Ed 02 2012 Pag 17 28 User Manual Spes Medica S r l recording files chronologically in order to have a temporal order of creation of them v1 1 Ed 02 2012 Pag 18 28 brux User Manual Spes Medica S r l 8 TROUBLESHOOTING This section describes the most common problems that may be found by Bruxoff users After pushing the ON OFF button the Memory not available if the problem persists The LED 2 red stays on Low Battery Charge the battery before using the The LED 2 red flashes Battery almost low but charged enough to record The status LED green does not The recording did not started Push the ON OFF flashes button again If the problem persists contact the manufacturer No file saved at the end of the The recording did not started check that after recording pushing the ON OFF button the green status LED starts to flash v1 1 Ed 02 2012 Pag 19 28 GrUxe User Manual Spes Medica S r l 9 BRUXOFF MAINTENANCE AND STORAGE Bruxoff device has to be used transported and stored in the following conditions Temperature from 10 C to 40 C Maximum relative humidity from 30 to 75 Atmospheric pressure from 700 hPa to 1060 hPa It is recommended to turn off the Bruxoff device at the end of every session Bruxoff should be stored with all the enclosed accessories on a safe place far from all the conditions described in
4. software can download and then process the data The second function is that of charging the battery once connected to a PC Fig 9 Cable for data downloading battery charge The connection to the PC and charging of the Bruxoff device is allowed only in the operator office or clinic not at home Only the operator can use the USB cable in order to charge the battery it should not be given to the patient System Requirements for PC connection 1 Windows Operating system for PC Windows XP Vista Windows 7 2 USB port Use the USB cable that you find in the kit v1 1 Ed 02 2012 Pag 15 28 GrUxe User Manual Spes Medica S r l Behaviour of the device during battery charge process During the battery charge process the green LED on the front side of the Bruxoff flashes When the device is fully charged the LED stays on Charge the device for at least 10 hours before to use it Application of the Bruxoff Device How to apply the Bruxoff system correctly e connect the multipolar connector of the patient cable to the multipolar connector on the Bruxoff device e take the CoDe electrodes and remove the protective liner then apply them as shown in fig 5 that is to say in direct contact with the masseter muscles e Without removing the protective liner of the array of electrodes for the detection of the heart rate REF CDESBRUX24 place the electrode on a flat surface an lay upon it the chest belt so that the
5. three holes of the chest belt lay upon the three button on the electrode e Take the three clips of the patient cable numbered with the numbers 1 2 3 and connect them to the buttons of the Array of adhesive electrodes pushing the cables trough the holes numbered with the number 1 2 3 of the chest belt Note the clip number 1 must be connected to the central clip of the Array of electrodes of detection of the heart rate REF CDESBRUX24 e Wear the chest belt and the Array of electrodes as shown in fig 2 and wear it tight enough so that the electrodes previously applied are under the left pectoral muscle and in direct contact with the skin e Connect the two concentric connectors numbered with the number 4 and 5 to the respective concentric connectors of the CoDe electrodes e Push the ON OFF button with a pen or something similar to start the recording Be sure that the status LED is flashing green If the LED does not flash go to section 10 of this manual troubleshooting v1 1 Ed 02 2012 Pag 16 28 GrUxe User Manual Spes Medica S r l e Insert the Bruxoff device in the appropriate pocket of the chest belt and get ready to go to sleep e Grind the teeth three times with the maximum clenching force and go to sleep Each clenching should last about two seconds with five seconds of rest between each clenching e When the patient wakes up push the ON OFF button again with a pen or something similar to stop the recording
6. 601 1 2 Law If the user connects the Bruxoff device to any other unauthorized device following the EN 606011 and EN 60601 1 2 Laws he she has to ensure that the combined use of the two devices follows the laws above mentioned Otherwise Spes Medica S r l shall not be held liable for accidents and or injuries to persons or damage For the features of the software read the Software Manual v1 1 Ed 02 2012 Pag 3 28 berux User Manual Spes Medica S r l 1 INDEX 1 GENERAL DESCRIPTION ws hretacecdcacarerscorscntseenmensensennieoendeneattonaeienrs pag PAMPER USE dbeseresrscrrecardinesespsivederrieveterrbsstenieesinenHieeE pag 3 PLACE OF USE vecieeeeetcsitee te terested pag A USER PROFILE ai eects eeccececeecedeccnccete eeceieeceendeneueeeceneeeeusneneniats pag 5 SAFETY PRECAUTIONS AND WARNINGS cee ccee ee eeees pag 6 CONTENT OF THE BRUXOFF SYSTEM ccccccccseseeeeeeeeeeeees pag 7 DETAILED DESCRIPT ION eee ncusaeacnsectcasnsattancasastoucaseeicasneaseusatawnacens pag Patient Cable ene eee ae te ee ste leer envee Serer eslan oere rusted sweetest wees resents ene pag CoDe le sa veresecvtecsne ced ecneeryiecesecuieceeacitereresyetcreeeeteeeree ee pag Application of CoDe electrodes cccceccccseeeeceeseeeeeseeseeeeeeeeeeeeas pag Array of electrodes for the detection of heart rate pag 12 Application of the array of electrodes for the detection of heartrate pa
7. BUT NOT INCLUDED IN THE STANDARD EQUIPMENT KITBRUX002 KIT contains the following codes CoDe adhesive concentric CODEXX1500 electrode with 15 cm cable and YES two pin plug Array of self adhesive surface CDESBRUX24 electrodes for the detection of the YES heart rate Use of the equipment accessories and or C accessories of the Spes Medica s r l to be used for the detection of the electromyography signals v1 1 Ed 02 2012 Pag 8 28 brux User Manual Spes Medica S r l 7 DETAILED DESCRIPTION Controls indicators and connectors of the Bruxoff system are shown in Fig 1 and described in the following sections Connector ON OFF button LED 2 Front View Status LED ul Back view Connector LED 1 battery Fig 1 Front view and Back view of the Bruxoff system Description of controls indicators and connectors shown in fig 1 Power Electrodes Connector It is the connector to which the adapter should be connected for the detection of the signals and charge battery download data connector To switch on the device the patient cable connector must be connected to the device v1 1 Ed 02 2012 Pag 9 28 GrUxe User Manual Spes Medica S r l LED 1 battery This is the only LED on the front side of the Bruxoff This LED flashes on and off when in charge and the light stays on green when the battery is 100 charged or when the device is on charge and connected to the PC LED 2 batter
8. d or operators by Spes Medica S r l will forfeit entitlement to warranty Spes Medica S r l denies any and all responsibility for damages caused directly or indirectly as a result of maintenance replacement of parts modifications and or reparations made by Companies and or operator that are not authorized by the Spes Medica S r l Bruxoff does not need any prior maintenance J WARRANTY Spes Medica S r l ensures that every new product has no defects due to materials and labour and will repair and or replace in warranty products used following the intended use and used in the use conditions described in this manual Warranty lasts 2 years only after filling and signature of the warranty application form that you find below Warranty conditions the obligations of Spes Medica S r l following the warranty are limited exclusively to what follows reparation will be made by and no later than 30 work days after the receipt of the product and only after the verification that the malfunctioning is not due to inadequate or inaccurate use maintenance and or reparation v1 1 Ed 02 2012 Pag 25 28 GrUxe User Manual Spes Medica S r l If Spes Medica S r l verifies that the malfunctioning is not due to inadequate or inaccurate use or unauthorized maintenance reparation the reparation costs materials and labour will be invoiced only after acceptation of the budget of reparation by the owner These warranty conditions substitu
9. e Remove the electrodes and disconnect them from the chest belt Disconnect the patient cable from the Bruxoff device and then put the device and its accessories chest belt and patient cable back in its packaging Throw away the single use CoDe electrodes and the electrodes for the detection of the heart rate after use The single use CoDe electrodes and the electrodes for the detection of the heart rate cannot be reused Memory file Files are saved on the Micro SD Card with a standard name The name structure is BRUXOFFn BRX Where n is the number of recordings increasing every time the button ON OFF is pushed lt can assume values in numbers and values in letters as well 0 1 2 8 9 A B Z so that in the system can coexist up to 36 different files If all the 36 available recordings have been made Bruxoff does not allow the uploading of new files The user should copy and delete the files on the Micro Sd Card in order to have new file names to be used again Every time the device is turned off that is to say disconnected from the connector the numbering of the files restart from BRUXOFFO BRX The Bruxoff device does not have a clock so the date and the time of the file do not display the moment in which they are saved Time and date start from 00 00 of the 1 January 2012 and increase of 1 hour with every new recording The Bruxoff0 brx file will be saved with the date 1 1 2012 and time 00 00 the Bruxoff1 orx will be
10. f electrodes for the detection of the heart rate REF CDESBRUX24 The Bruxoff system uses an array of 3 surface adhesive electrodes for the detection of the heart rate In fig 6 an image of the array Fig 6 Array of adhesive electrodes for the detection of the heart rate N Avoid contact between the electrodes connected to the device but not applied yet and the conductor parts connected to the ground connection v1 1 Ed 02 2012 Pag 13 28 bux User Manual Spes Medica S r l Application of the Array of electrodes for the detection of the heart rate Fig 7 Application of the Array of adhesive electrodes The chest belt of the Bruxoff device The Bruxoff device uses a chest belt that includes the system with a belt in the chest belt itself This belt overlaps the array of electrodes for the detection of the heart rate in order to ensure a good contact between the electrode and the skin Fig 8 Chest Belt v1 1 Ed 02 2012 Pag 14 28 GrUxe User Manual Spes Medica S r l Application of the chest belt of the Bruxoff device Apply the chest belt of the Bruxoff device as shown in fig 2 and as described in the section Application of the Bruxoff system USB cable charge battery and PC connection The Bruxoff device has an USB cable as shown in fig 9 and the operator but not the patient uses it as a double function cable The first function is that of connecting the Bruxoff to a PC so that the
11. g Baa Mee ew a EE EEEE E esis nian ap ea ee ee pag Application of the chest belt ccecccceecsseeeseeeeseeeseeeseeeeseeeenees pag USB cable for battery charge process and PC connection pag System requirements for PC CONNECTION ccccececeeeeeeeeeeeeeeeeees pag Behaviour of the device during battery charge process pag Application of the Bruxoff G VICE cccecccseccceeeeeeeeseeeseeeeneeeseeeees pag Memory file wet canine nice eiueatantnnennaccusen diac enanasaananaasat ncaa peateaccbaeaeeensaaienenban pag D We ea oes ceeeccceraarerarernsasnraarmraenrareseumecemereseieee pag 9 MAINTENANCE AND STORAGE ccccccceescceeeseeeceeeeeeeeeeeseaeaees pag Leoning me O VCE a ee ae en EE terest terrae eer pag Disposal of the device cote cise eeacstnpasatcaceebatducaaiensaerencnraaneemeeee pag Life span of the device n nnnannnannnnnennnnennonnnnnnnnnernnnnnrnnnernnernrennnee pag 10 TECHNICAL SPECIFICATIONS cc ccccccccceeeeeeeeeeeeeeeseaeeeeeees pag le Pe PUN cesi chasse inininieoeieauusieaninieeasiineoe pag Information about the Electromagnetic compatibility pag CUSTOMER SERVICE cccccccccesseececeesseeeecseseeeeceeaseeeecseuseeeesseas pag WARRANTY sett aecereseveyecesezenecesereseven eres NE E EE EEI EESE EIEE NE pag Bruxoff warranty activation form wscssssrnscersansacnisrntardagerineticensanincsnaas
12. his product as unsorted municipal waste Collection of such waste separately for special treatment of necessary following the 2002 96 EC of the European Parliament and European Council on waste electrical and electronic equipment WEEE The regulation is not valid in case of corrupted product The Bruxoff system is produced in order to last if the use and maintenance conditions indicated in this Users manual are followed but the life span of the device is determined by the life span of the battery 5 years After this period it is recommended to take the device to the manufacturer every two years v1 1 Ed 02 2012 Pag 21 28 GrUxe User Manual Spes Medica S r l 10 TECHNICAL SPECIFICATIONS The Bruxoff device is a battery system designed following the medical regulations in order to ensure the patient safety The signal amplified by the system is saved as a proprietary file on a non removable MicrdoSdcard inside the system In table 1 there are the technical specifications of the Bruxoff system BruxOff Classification Battery system Degree of Protection IP32 Case Metallic case Power Supply 3 7V Battery rechargeable Battery time 36 Hours full charge Charging time 19 hours Class 4 of which 3 used 972 uVpp 13 400Hz Number of Channels Dynamics Band lt 2 uVrus Amplification 3 393 V V 2 Input impedance gt 90 MQ on the entire bandwith CMRR gt 96 dB Output Dynamics 0 3 3 V 8 bi
13. k should be ground mode that of a common hospital business 1 kv phase i 1 kv differential environment phase i mode Overvoltages 2 kV phase i 2 kV common The quality of the voltage network should be ground 1 kv mode that of a common hospital obusiness phase i phase i 1 kv differential environment mode Voltage lt 5 Ut lt 5 Ut The quality of the voltage network should be interruptions short 95 of 95 of that of acommon home business interruptions and interruption interruption environment If the Bruxoff user calls fora variations of for 0 5 cycles for 0 5 cycles continuative work even during the voltage voltage on the input lines network interruption charge Bruxoff with a 40 Ut 40 Ut uninterruptible power source 60 of 60 of interruption interruption for 5 cycle for 5 cycles 70 Ut 70 Ut 30 of 30 of interruption interruption for 25 cycles for 25 cycles lt 5 Ut lt 5 Ut 95 of 95 of interruption interruption for 5 seconds for 5 seconds Mag at the 3 A m 3 A m The frequency magnetic field must have network home business environment levels frequency 50 Hz v1 1 Ed 02 2012 Pag 23 28 GrUxe User Manual Spes Medica S r l Table 202 IMMUNITY Immunity Test Test Level Conformity Electromagnetic environment guide 60601 1 2 Levels d 1 17 VP Where P is the maximum output power of the Conducted Radio transmitter in W by the manufacturer of the F
14. les and the heart rate the Bruxoff needs the cable for the connection of the electrodes This cable is shown in fig 3 Fig 3 Patient Cable B v1 1 Ed 02 2012 Pag 11 28 GrUxe User Manual Spes Medica S r l An end of this cable ends with a multipolar connector the other end is divided in 5 different cables every cable ends with the following connector A female clip identified with the number 1 to be used to connect the reference connector that will be placed inside the chest belt in the position identified with number 1 two female clips identified with numbers 2 and 3 to be used to connect the adhesive chest belt and that will be placed inside the chest belt in the positions identified with numbers 2 and 3 they will detect the heart rate Two concentric connector identified with numbers 4 and 5 to be used to connect the CoDe concentric electrodes for the detection of the EMG signals from the masseter muscles CoDe Electrodes Concentric Detection The Bruxotf system uses two concentric electrodes for the detection of the electromyography signals from the masseter muscles called Code In fig 4 an image of the CoDe concentric electrode Fig 4 CoDe Electrodes v1 1 Ed 02 2012 Pag 12 28 brux User Manual Spes Medica S r l Application of the CoDe Electrodes Concentric Detection Apply the CoDe electrodes as shown in fig 5 electrodes Fig 5 Application of the CoDe Array o
15. ligation under this warranty is limited to repairing or replacing any defective part provided that the unit is returned unmodified to Spes Medica S r l and that the defect has occurred within one year of the original date of purchase A handling postage charge will be at charge of the Customer This warranty is void if the purchaser has not returned a copy of this document signed by the responsible party of the purchaser and completely executed Spes Medica S r l expressly disavows any medical liability for the improper use of this device This warranty does not apply is void to any unit which has been repaired in any way or modified by unauthorized personnel or which has been subject to misuse neglect or accident or which has had the serial number altered or removed v1 1 Ed 02 2012 Pag 27 28 User Manual Spes Medica S r l Manufactured by Spes Medica srl Via Europa Zona Industriale 84091 Battipaglia Sa ITALY www spesmedica com e mail info spesmedica com Designed in collaboration with and Distributed by OT Bioelettronica C so Unione Sovietica 312 10135 Torino TO ITALY www otbioelettronica it e mail mail otbioelettronica it v1 1 Ed 02 2012 Pag 28 28
16. omyography measurements and consequently the physiological variables calculated on the basis of the information detected For this reason do not use it near devices that could cause the problems described above for example mobile phones instruments with power transformer etc e The operator must be sure that the battery of the device is completely charged following what is indicated in this User s Manual before to give the device to the patient e The device must be kept out of reach of children or unsound mind patient e Do not clean the device using acetone ether freon oil products or any other solvent e Do not use soap or water on the connector pin e Do not clean Bruxoff or connection cables with water in autoclave or steam cleaning AN The device must not be used in any other way than indicated in these instructions v1 1 Ed 02 2012 Pag 7 28 GrUxe User Manual Spes Medica S r l 6 CONTENT OF THE BRUXOFF KIT ACCESSORIES AND DOCUMENTS R Deseripton Featwes USB connection cable battery NON sia charge and PC connection STERILE paneer Connection cable for the NON ren recording electrodes STERILE MASABE NON BRUXBELT000 Chest belt with device STERILE RIUSABILE BRUXMETERSW CD ROM with Bruxmeter software BRUXMANSW Bruxmeter software manual NR The accessories of the machine indicated above are to be considered as part of the device itself so they are not subject to marking ACCESSORIES NEEDED
17. pag v1 1 Ed 02 2012 o o o a a A 12 12 14 14 14 19 15 15 16 17 18 19 19 20 20 21 22 22 24 24 26 Pag 4 28 GrUxe User Manual Spes Medica S r l 2 GENERAL DESCRIPTION The BruxOff device is a three canals Holter This system has been designed to detect the surface electromyography signal SEMG from the two masseter muscles trough the use of the concentric electrodes called CoDe in addition to the heart rate detected with three surface electrodes inside the chest belt The information detected from the electrodes is then saved on a non removable Micro SD card inside the device The Bruxoff system works with a software called Bruxmeter in order to display and process the data This software is part of the Bruxoff system and it is also possible to download it free on the website www bruxoff com in the Downloads section 3 INTENDED USE BruxOff has been designed to be used as an electromyography Holter to monitor Bruxism The device is not intended to be used near inflammable anaesthetics N The device is not intended to be used for an electrocardiographic exam 4 PLACE OF USE BruxOff is intended to be used as a home device and a hospital device as a home device the patient uses the device at home during the night and as a hospital device the operator uses the information detected from it in order to make a diagnosis v1 1 Ed 02 2012 Pag 5 28 GrUxe User Manual Spes Medica S r
18. requency 3 Veff 3 Veff transmitter and d is the distance of separation in metres d 0 35 4P from 80 MHz to 800 MHz d 0 7 VP from 800 MHz to 1 GHz 10 V m 26 d 2 33 P from 1 GHz to 2 5 GHz Irradiated Radio MHz 1 GHz 10 V m Where P is the maximum output power of the Frequency 3 V m 3 V m transmitter in W by the manufacturer of the 1GHz 2 5GHz transmitter and d is the distance of separation in metres DISTANCE OF SEPARATION RECOMMENDED BETWEEN PORTABLE AND MOVABLE COMUNICATION DEVICES AND THE BRUXOFF DEVICE Bruxoff is made to work on an electromagnetic environment where the radiofrequency distortions are under control The Bruxoff user or operator can avoid electromagnetic interferences ensuring a minimum distance between the RF transmitters movable and portable communication devices and as described below in relation to the maximum output power of the radio communication devices Distance of separation to the transmitter frequency m Maximum Output power of the transmitter W From 15 kHz to From 80MHz to From 800MHz to From 1GHz to conn goon Gre escHe v1 1 Ed 02 2012 Pag 24 28 GrUxe User Manual Spes Medica S r l JN CUSTOMER SERVICE Bruxoff has no parts that can be replaced or repaired by the user contact the distributor for assistance so that he she can repair or replace the products under warranty Maintenance and replacement of parts modifications and or reparations made by unauthorized Companies an
19. te all the other warranty conditions explicit or implicit included but not within limits of the general conditions specified in the international sale regulations Spes Medica S r l reserves the right to refuse the reparation of any products sent by the user for reparation this refusal will be conveniently explained The only obligation of Spes Medica S r l is that of returning the product to the user at its own expenses v1 1 Ed 02 2012 Pag 26 28 User Manual Spes Medica S r l BruxOff WARRANTY ACTIVATION FORM a copy of this module filled and signed by the Costumer must be sent back by e mail fax or mail to Spes Medica S r l Via Europa Zona Industriale 84091 Battipaglia SA Italy Tel 39 0 828 614191 fax 39 0 828 341788 e mail info spesmedica com TO BE FILLED BY THE CUSTOMER BruxOff Serial Number Pe BruxOff Date of Sale re Purchase Address o E To be covered by warranty you must certify that Your BruxOff will be used only according with User s Manual All unexpected occurrences and malfunction associated with the BruxOff will promptly be reported to Spes Medica S r l Via Europa Zona Industriale 84091 Battipaglia SA Italy I declare to have understood and accepted the Warranty terms Stamp and Signature Spes Medica S r l warrants the BruxOff to be free from defects in material or factory workmanship in the course of normal use and service The manufacturer s ob
20. the section Warnings of this manual Bruxoff does not need any particular maintenance procedure to work To maintain the battery efficiency recharge the device before every use and check regularly the efficiency status of the battery J lf during the use and after the battery charging the battery lasts less than 3 hours contact the manufacturer to check the controls of the electrical source Itself Cleaning the device At the end of every use clean the Bruxoff with a clean cloth e A Do not clean Bruxoff using acetone ether freon oil products or any other solvent Do not use soap or water on the connectors pin contacts Do not clean Bruxoff or its cables with water in autoclave or with steam cleaning WARNING clean the electrodes connection cable only with hospital disinfectants before every use to avoid microbial contamination between patients and healthcare professionals Product Disposal The Bruxoff system contains electronic parts that must be disposed of as e waste Dispose the device and the accessories following local regulations Follow the disposal regulations of your country in order to ensure the correct disposal of the Bruxoff device and its v1 1 Ed 02 2012 Pag 20 28 User Manual Spes Medica S r l accessories For further information about the disposal of this device contact the Environment Department and local authority Life span of the device N Warning Do not dispose t
21. ts Micro SD inside the device 800 Hz 1 button 59 x 95 x 10 mm 110g A D converter resolution Data memory Sampling rate Commands Weight TAB 1 Technical Specifications of the Bruxoff System v1 1 Ed 02 2012 Pag 22 28 GrUxe User Manual Spes Medica S r l 11 APPENDIX Information from the Manufacturer in reference to the electromagnetic compatibility of the Bruxoff device The Bruxoff device is designed and made to work in an electromagnetic environment with the following conditions The Bruxoff user must ensure that it is used in these conditions Conformity Electromagnetic Environment guide RF Emissions Gruppo 1 The Bruxoff product uses the RF energy only for its inner functioning so its RF emissions are very low and most likely it does not cause any interference with the electronic devices in the same environment RF Emissions B Class The Bruxoff product can be used in every environment at home and where there is an electrical grid that supplies houses buildings Harmonic Emissions AClass o Flicker Emissions Adequate oo O Table 202 IMMUNITY Immunity Test Test level Conformity level Electromagnetic environment guide 60601 1 2 Electrostatic 6 kV contact 6 kV contact Pavements must be of wood piling ceramic charge 8kv air 8kv air If pavements are of synthetic material relative humidity must be at least 30 Transients 2 kV phase i 2 kV common The quality of the voltage networ
22. y This LED is on the right side of the back of the Bruxoff It is identified by the symbol of the battery This LED is normally turned off when the battery level is enough to allow the recording of the exam while when it starts to flash red means that it is possible to record one last exam when the LED light stays on red the system is not recording anymore When the battery LED on the right side of the back of the Bruxoff identified by the battery symbol stays on red light the device is not recording anymore In that case contact the operator so that he she can charge the battery before making another exam Status LED This LED is on the left side of the back of the Bruxoff and it stays on green light when the Bruxoff device is in stand by This LED starts flashing after pushing the ON OFF button to confirm that the device is on and detecting signals ON OFF button Pushing this button with a pen or something similar it is possible to start and stop the data capture N If after pushing the ON OFF button the Status LED is not flashing the data capture did not started Push the ON OFF button again If the problem persists contact the manufacturer v1 1 Ed 02 2012 Pag 10 28 brux User Manual Spes Medica S r l In fig 2 it is shown how the Bruxoff system should be worn by the patient Fig 2 Patient wearing the Bruxoff system Patient Cable to detect the electromyography signals produced by the masseter musc
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