foremg - OT Bioelettronica
Contents
1. foremg does not need any prior maintenance N 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 3 Ed 06 2013 Pag 19 22 OT Bioelettronica snc 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 substitute 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 The2. The foremg 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 foremg Model foremg Classification Battery system Degree of Protection IP32 Case Metallic case Power Supply 3 7V Battery rechargeable Battery time 36 Hours full charge Charging time 5 hours Class Numbers of Channels 4 Dynamics 972 uVpp Band 13 400Hz Input Noise lt 2 UVRMS Amplification 3 393 VN 2 Input impedance gt 90 MQ on the entire bandwith CMRR gt 96 dB Output Dynamics 0 3 3V A D converter resolution 8 bits Data memory Micro SD inside the device Sampling rate 800 Hz Commands 1 button Dimensions 59 x 95 x 10 mm Weight 110g TAB 1 Technical Specifications of the foremg v1 3 Ed 06 2013 Pag 16 22 OT Bioelettronica snc 11 APPENDIX Information from the Manufacturer in reference to the electromagnetic compatibility of the foremg User Manual Spes Medica S r l EMISSIONS The foremg device is designed and made to work in an electromagnetic environment with the following conditions The foremg user must ensure that it is used
3. battery before making another exam Status LED This LED is on the left side of the back of the foremg and it stays on green light when the foremg 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 A 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 foremg system should be worn by the patient Patient Cable to detect the electromyography signals produced by muscles foremg needs the cable for the connection of the electrodes 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 used to connect the reference electrode to the foremg the reference electrode has to be placed in a point without EMG activity Four concentric connector identified with numbers 1 2 3 and 4 to be used to connect the CoDe concentric electrodes for the detection of the EMG signals from selected muscles v1 3 Ed 06 2013 Pag 9 22 OT Bioelettronica snc User Manual Spes Medica S r l The chest belt of the foremg device The foremg device uses the bruxoff chest belt Fig 2 Chest Belt USB cable charge
4. in these conditions Test of emissions Conformity Electromagnetic Environment guide RF Emissions Gruppo 1 The foremg 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 foremg product can be used in every environment at home and where there is an electrical grid that supplies houses buildings Harmonic Emissions A Class Flicker Emissions Adequate 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 network 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 business phase i phase i 1 kv differential environment mode Voltage 5 Ut 5 Ut The quality of the voltage network should be interruptions short 95 of 95 of that of a common home business interruptions and interruption interruption environment
5. only obligation of Spes Medica S r l is that of returning the product to the user at its own expenses v1 3 Ed 06 2013 Pag 20 22 OT Bioelettronica snc User Manual Spes Medica S r l foremg 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 foremg Serial Number foremg Date of Sale Purchase Adaress City Country ZIP CODE Tel fax e mail To be covered by warranty you must certify that Your foremg will be used only according with User s Manual All unexpected occurrences and malfunction associated with the foremg 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 Date Spes Medica S r l warrants the foremg to be free from defects in material or factory workmanship in the course of normal use and service The manufacturer s obligation 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 purch
6. ARNING clean the electrodes connection cable only with hospital disinfectants before every use to avoid microbial contamination between patients and healthcare professionals Product Disposal The foremg 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 foremg and its accessories For v1 3 Ed 06 2013 Pag 14 22 OT Bioelettronica snc User Manual Spes Medica S r l further information about the disposal of this device contact the Environment Department and local authority Life span of the device A Warning Do not dispose this 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 foremg 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 3 Ed 06 2013 Pag 15 22 User Manual 10 TECHNICAL SPECIFICATIONS OT Bioelettronica snc Spes Medica S r l
7. CE foremg is made to work on an electromagnetic environment where the radiofrequency distortions are under control The foremg 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 Maximum Output power of the Distance of separation to the transmitter frequency m transmitter W From 15 kHz to From 80MHz to From 800MHz to From 1GHz to 80MHz 800MHz 1GHz 2 5GHz 0 01 0 12 0 04 0 07 0 23 0 1 0 37 0 11 0 22 0 74 1 1 17 0 35 0 70 2 33 10 3 69 1 11 2 21 7 38 100 11 67 3 50 7 00 23 33 v1 3 Ed 06 2013 Pag 18 22 OT Bioelettronica snc User Manual Spes Medica S r l N CUSTOMER SERVICE foremg 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 and or operators by Spes Medica S r l will forfeit entitlement to warranty Spes Medica S r 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
8. GENERAL DESCRIPTION The foremg device is a four channel Holter This system has been designed to detect the surface electromyography signal SEMG from four muscles trough the use of the concentric electrodes called CoDe or using standard bipolar electrodes The information detected from the electrodes is then saved on a non removable Micro SD card inside the device The foremg works with a software called OT BioLab in order to display and process the data This software is part of the foremg system and it is also possible to download it free on the website www otbioelettronica it in the Downloads section 2 INTENDED USE foremg has been designed to be used as an electromyography Holter to monitor muscles activity N The device is not intended to be used near inflammable anaesthetics A The device is not intended to be used for an electrocardiographic exam 3 PLACE OF USE foremg 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 day and as a hospital device the operator uses the information detected from it in order to make a diagnosis v1 3 Ed 06 2013 Pag 5 22 OT Bioelettronica snc User Manual Spes Medica S r l 4 USER PROFILE USER Patient a Age gt 15 years old b Weight not important c Health no heart problems or pacemakers d Nationality not important e Patient status able to understand the use of foremg Education level H
9. If the foremg user calls for a variations of for 0 5 cycles for 0 5 cycles continuative work even during the voltage voltage on the network interruption charge foremg with a input lines EF oot uninterruptible power source 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 3 Ed 06 2013 Pag 17 22 OT Bioelettronica snc User Manual Spes Medica S r l Table 202 IMMUNITY Immunity Test Test Level Conformity Electromagnetic environment guide 60601 1 2 Levels d 117 VP Where P is the maximum output power of the Conducted Radio transmitter in W by the manufacturer of the Frequency 3 Veff 3 Veff transmitter and d is the distance of separation in metres d 0 35 JP from 80 MHz to 800 MHz d 0 7 P from 800 MHz to 1 GHz 10 V m 26 d 2 33 4 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 FOREMG DEVI
10. OT Bioelettronica snc User Manual Spes Medica S r l User s Manual foremg AN Read this manual carefully before using foremg 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 3 Ed 06 2013 Pag 1 22 OT Bioelettronica snc User Manual Spes Medica S r l medica ER WA WI EA PP the medical c Aw p 7 accessoties 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 v1 3 Ed 06 2013 Pag 2 22 OT Bioelettronica snc 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 Serial Number Device with BF parts 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 Manufacturer 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
11. ase 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 Notes v1 3 Ed 06 2013 Pag 21 22 OT Bioelettronica snc 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 3 Ed 06 2013 Pag 22 22
12. battery and PC connection The foremg device has an USB cable as shown in fig 3 and the operator but not the patient uses it as a double function cable The first function is that of connecting the foremg to a PC so that the software can download and then process the data The second function is that of charging the battery once connected to a PC Fig 3 Cable for data downloading battery charge N The connection to the PC and charging of the foremg 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 N Use the USB cable that you find in the kit v1 3 Ed 06 2013 Pag 10 22 OT Bioelettronica snc 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 foremg flashes When the device is fully charged the LED stays on N Charge the device for at least 4 hours before to use it Application of the foremg How to apply the foremg system correctly e connect the multipolar connector of the patient cable to the multipolar connector on the foremg device e take the electrodes and remove the protective liner then apply them that is to say in direct contact with the investigated muscles
13. disposal of e waste The foremg device has been tested in reference to the EN 60601 1 and the EN 60601 1 2 Law If the user connects the foremg 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 3 Ed 06 2013 Pag 3 22 OT Bioelettronica snc 1 GENERAL DESCRIPTION 2 INTENDED USE 3 PLACE OF USE 4 USER PROFILE 5 SAFETY PRECAUTIONS AND WARNINGS 6 CONTENT OF THE FOREMG SYSTEM 7 DETAILED DESCRIPTION Patient Cable Chest belt USB cable for battery charge process and PC connection System requirements for PC connection Behaviour of the device during battery charge process Application of the foremg device Memory file 8 TROUBLE SHOOTING 9 MAINTENANCE AND STORAGE Cleaning the device Disposal of the device Life span of the device 10 TECHNICAL SPECIFICATIONS 11 APPENDIX Information about the Electromagnetic compatibility CUSTOMER SERVICE WARRANTY foremg warranty activation form v1 3 Ed 06 2013 User Manual 1 INDEX Spes Medica S r l N Oo Oo Ci OC oO x 10 10 rm Ma 11 12 13 14 14 ae i 2735 VU I7 r 19 19 nel Pag 4 22 OT Bioelettronica snc User Manual Spes Medica S r l 1
14. e been made foremg 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 EMG4CH_0 BIO The foremg 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 foremgO bio file will be saved with the date 1 1 2012 and time 00 00 the foremg1 bio will be saved with the date 1 1 2012 and time 01 00 etc Order the recording files chronologically in order to have a temporal order of creation of them v1 3 Ed 06 2013 Pag 12 22 OT Bioelettronica snc User Manual Spes Medica S r l 8 TROUBLESHOOTING This section describes the most common problems that may be found by foremg users Problem Description How to deal with it After pushing the ON OFF button the LED 2 red stays on Memory not available if the problem persists contact the manufacturer The LED 2 red stays on Low Battery Charge the battery before using the device The LED 2 red flashes Battery almost low but charged enough to record one last exam The status LED green does not flashes The recording did not started Push the ON OFF button again If the probl
15. e Take the clip of the reference cable and connect it to the reference electrode displaced on a point without EMG activity e Wear the chest belt e Connect the four concentric connectors numbered with the number 1 2 3 and 4 to the respective concentric connectors of 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 e Insert the foremg in the appropriate pocket of the chest belt and get ready to go to make the acquisition e To stop the acquisition push the ON OFF button again with a pen or something similar to stop the recording e Remove the electrodes and disconnect them Disconnect the patient cable from the foremg and then put the device and its accessories chest belt and patient cable back in its packaging Throw away the single use electrodes N The single use bipolar electrodes cannot be reused v1 3 Ed 06 2013 Pag 11 22 OT Bioelettronica snc User Manual Spes Medica S r l Memory file Files are saved on the Micro SD Card with a standard name The name structure is EMGACH n BIO Where n is the number of recordings increasing every time the button ON OFF is pushed It 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 hav
16. 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 Do not clean foremg 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 6 CONTENT OF THE FOREMG KIT ACCESSORIES AND DOCUMENTS Description Features USB connection cable battery NON GUSB charge and PC connection STERILE MEUSABEE Connection cable for the NON PERITO recording electrodes STERILE NON BRUXBELTOOO Chest belt with device STERILE RIUSABILE RIUSABILE N The accessories of the machine indicated above are to be considered as part of the device itself so they are not subject to C marking ACCESSORIES NEEDED BUT NOT INCLUDED IN THE STANDARD EQUIPMENT CDE02401500BX Bipolar Electrodes NO YES N 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 3 Ed 06 2013 Pag 7 22 OT Bioelettronica snc User Manual Spes Medica S r l 7 DETAILED DESCRIPTION Controls indicators and connectors of the foremg a
17. em persists contact the manufacturer No file saved at the end of the recording v1 3 Ed 06 2013 The recording did not started check that after pushing the ON OFF button the green status LED starts to flash Pag 13 22 OT Bioelettronica snc User Manual Spes Medica S r l 9 FOREMG MAINTENANCE AND STORAGE foremg 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 foremg at the end of every session foremg should be stored with all the enclosed accessories on a safe place far from all the conditions described in the section Warnings of this manual foremg 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 A If 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 foremg with a clean cloth AN Do not clean foremg using acetone ether freon oil products or any other solvent N Do not use soap or water on the connectors pin contacts A Do not clean foremg or its cables with water in autoclave or with steam cleaning A W
18. igh 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 foremg 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 3 Ed 06 2013 Pag 6 22 OT Bioelettronica snc User Manual Spes Medica S r l The foremg could be sensitive to electromagnetic interferences of other devices that could alter its electromyography 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
19. re shown in Fig 1 and described in the following sections Connector ON OFF Button LED 2 Frontal View Status Led Posterior View Connector LED 1 battery Fig 1 Front view and Back view of the foremg 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 A To switch on the device the patient cable connector must be connected to the device v1 3 Ed 06 2013 Pag 8 22 OT Bioelettronica snc User Manual Spes Medica S r l LED 1 battery This is the only LED on the front side of the foremg This LED flashes on and off when in charge and the light stays on green when the battery is 10096 charged or when the device is on charge and connected to the PC LED 2 battery This LED is on the right side of the back of the foremg 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 A When the battery LED on the right side of the back of the foremg 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
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