Trentadue - OT Bioelettronica
Contents
1. A The accessories of the machine indicated above are to be considered as part of the device itself so they are not subject to C E label TRENTADUE AVAILABLE ELECTRODES CODE401500 501500 Concentric Detection electrodes ros 16 channels and 32 channels ELSCH016 ELSHO32 semidisposable arrays and matrixes Adhesive foam for the ELSCH016 KITADO16 KITADO32 array and for the ELSCHO32 matrix v1 3 Ed 11 2015 Pag 7 21 OIG OT Bioelettronica snc User Manual NZ elettronica 7 DETAILED DESCRIPTION Controls indicators and connectors of the Trentadue are shown in Fig 1 and described in the following sections Frontal View Posterior View Trasmission status LED Battery recharge LED Error status LED microSD card slot MicroSD Recharge Status Error Designed and Developed by OT Bioelettronica Torino Italy SN TD000X otbioelettronica it Trentadue ON OFF Adapters Recharge Fig 1 Front view and Back view of the Trentadue Description of controls indicators and connectors shown in fig 1 Adapters Recharge Connector adapter connector to interface electrode and recharge the battery Battery recharge LED this red LED switches on when recharging the internal battery It switch off when the battery is fully charged Status LED this green LED blink when Trentadue is creating the WiFi network it is on when the network has been created Battery Error LED this red LED indicates ba2. Ed 11 2015 Pag 17 21 OT Bioelettronica snc User Manual T elettronica Product Disposal The Trentadue 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 Trentadue and its accessories For further information about the disposal of this device contact the Environment Department and local authority A VVarning 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 Life span of the device The Trentadue system is produced in order to last if the use and maintenance conditions indicated in this User s 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 11 2015 Pag 18 21 OT Bioelettronica snc User Manual T elettronica 13 TECHNICAL SPECIFICATIONS The Trentadue device is a battery system designed following the medical regulations in order to ensure the patient safety The signal amplified by the system is transferred to a PC ina wirele
3. is set to 2000 Hz and the number of channels is equal to 32 6 the internal sampling frequency is 2000 but only one sample out of two is transmitted to fit the datarate of the WiFi module The 3dB corner of the internal low pass filter is equal to 1 4 fsamp oe oO oO oP dl oO The third number set the resolution Only 1 is valid and is 16 bits dO oo olo The fourth number indicates the type of adapter connected Can be O AD8XITR 2 AD16x1TR 3 Generic monopolar acquisition oe v1 3 Ed 11 2015 Pag 14 21 OT Bioelettronica snc User Manual oO This overwrite the number of channels when 18 lt 3 oO oO difference directly into the trentadue dO oo oO the number is set to 0 no AUX channel will be acquired For AD8x1ITR the AUX has to be set 3 For ADl6x1ITR the AUX has to be set 4 For AD1x32TR the AUX has to be set 4 dO dO dO dO dO oO For AD8x1TR the channel has to be set 8 For AD16x1TR the channel has to be set 16 For AD1x32TR the channel has to be set 32 dO oo oO a Q VICE CONCrOI SET 0O 3 1 U 3 8 8 channels 2000 Hz Differential device control SET 1 3 L L4 Le 16 channels 2000 Hz Differential lt d vice control SET 2 2 1 3 4 32 amp 32 channels 1000 Hz Monopolar O Read back the configuration device getConfig low pass filter d evice channelContig 3 2 nigh pass FLlrter device CchannelConrig 2 4 5 gain
4. your computer s privacy might be at risk Cancel To connect the operator has to create two bat files respectively for connection disconnection It can be done with a txt editor or can be provided by OT Bioelettronica 1 2 Open a new txt file Paste the string netsh wlan connect TrentadueXYX Save the file as ConnectTrentadueXYZ bat Repeat the same procedure in a second txt file with the string netsh wlan disconnect Save the file as DisconnectTrentadue bat From now on just double click on the file ConnectTrentadueXYZ bat when you need to connect to Trentadue or double click on DisconnectTrentadue bat to disconnect from Trentadue When test are over remember to double click on DisconnectTrentadue bat in order to free the device v1 3 Ed 11 2015 Pag 12 21 OT Bioelettronica snc User Manual T elettronica 9 FIRMWARE UPGRADE This section describes the upgrade of firmware that can be done by the user Proceed as follows e Turn off the Trentadue e Upload on a empty micro SD card the hex and cfg files provided by OT Bioelettronica e Pay attention to upload the files in the main folder and not in any subfolder e Plug the micro SD card in the Trentadue e Turn on the Trentadue e Trentadue s LEDs will start blinking in random order e Wait until they stop blinking e When they stop blinking turn off the Trentadue e Remove the micro SD card e Upgrade has been successfully
5. Bioelettronicasnc 6 UserManual g 3 elettronica User s Manual v 1 3 Trentadue A Read this manual carefully before using Trentadue OT Bioelettronica snc User Manual T elettronica v1 3 Ed 11 2015 Pag 2 21 OT Bioelettronica snc User Manual elettronica 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 Warning read the instructions before using the device This symbol could also be used as a Warning symbol Read the instructions of use 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 Trentadue device has been tested in reference to the EN 60601 1 and the EN 60601 1 2 Law If the user connects the Trentadue 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 OT Bioelettronica 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 11 2015 Pag 3 21 a qr OT Bioelettronica snc User Manual NZ elettronica 1 INDEX 1 GENERAL DESCRIPTION caisateiaimmsnsistdmmmtte
6. agnosis 4 USER PROFILE USER Specialized operator a Knowledge Minimum Basic notions about the human body b Languages Italian and or English c Experience Minimum training about the device use d Handicaps maximum reduction of the hearing of 40 with residual hearing at 60 maximum sight reduction of 40 with residual sight at 60 v1 3 Ed 11 2015 Pag 5 21 OT Bioelettronica snc User Manual T elettronica KIND OF PATIENT a Age gt 15 years b Weight Not Important c Health No cardiovascular problems no pacemakers d Nationality not relevant 5 SAFETY CAUTIONS AND WARNINGS The use of Trentadue 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 If the device falls in to the ground or something similar happens check that the device is undamaged In case of doubt contact the manufacturer The Trentadue could be sensitive to electromagnetic interferences of other devices that could alter its electromyography measurements and consequently the physiological variables calculated on the ba
7. completed v1 3 Ed 11 2015 Pag 13 21 OT Bioelettronica snc User Manual T elettronica 10 MATLAB CONNECTION This section shows the Matlab connection code to connect to Trentadue In order to connect to Trentadue you must use the code provided by OT Bioelettronica that can be found in the installation folder of OT Biolab Routine for the direct communication with Trentadue oO This Matlab scripts doesn t need OT BioLab to communicate with trentadue It opens a TCP socket set the configuration of trentadue and reads back data at the desired sampling frequency oO dO oo oO OT Bioelettronica August lith 2015 v Liz dO go oO close all clear all path cd javaaddpath path addpath path Warning DEL O NumCycles 20 How many times matlab reads data from trentadue GainFactor 4 8 2 167256 1000 oO Provide amplitude in mV 4 8 is the ADC input swing 2 16 is the resolution 256 is the gain 1000 to get the mV do AP oo oP oO AuxGainFactor 4 8 2716 Gain factor to convert Aux Channels in V device OTClient 192 168 1 1 9760 oO The SET command is used to configure the instrument oO oO The first number indicates the number of transmitted channels Can be O 8 channels 1 16 channels 2 32 channels oO go oO The second number set the sampling frequency Can be 0 250 Hz 1 500 dz 2 1000 Hz 35 2000 Hz Note when the samplig frequency
8. device channelConfig 1 nEMG device nEMG nAux device nAux Samplerate device Samplerate Start data transef device control start for 1 1 NumCycles amp Wait for 1 second to have some data pause 1 Read data Data i double device readData Plot the signals hold orf for ch 1 nEMG plot Date 1 ch Galnractor double ch 5 hold on end Display the number fo samples and channels received size Data 1i end oO Stop data transfer ll Important 111 During debug always stop data transfer before start a new dO oo oO device control stop O Close the communication device delete v1 3 Ed 11 2015 session otherwise the Sinchroni zation with trentadue is lost GBP IZ elettronica In particular the AD8x1TR and the AD16x1TR are used to set the The fifth number indicates whitch AUX channel has to be acquired If The sixth number indicates witch channel is replaced by the AUX channel 2 bytes 2 bytes 2 bytes Pag 15 21 OT Bioelettronica snc User Manual T elettronica 11 TROUBLESHOOTING This section describes the most common problems that may be found by Trentadue users Problem Description How to deal with it After the Trentadue switch on the Check the Battery charge Trentadue net has not been created Battery empty recharge it Or The red LED Error is switched on Data transmission error please move near to the PC
9. eck in the WiFi Networks An Ad Hoc Wi Fi Network named TrentadueXYZ will be available where XYZ are replaced by the device serial number Connect to the Trentadue s network How to connect to Windows 8 and Windows 10 PC 1 2 Turn on Trentadue Wait the green light to stop blinking When the green light is steady right click on the Network icon of the Taskbar am all 10 20 AM 9 8 2015 Choose Open Network and Sharing Center Troubleshoot problems Open Network and Sharing Center Set up a new connection or network Manually connect to a wireless network Fill the form as follows using the name of your own Trentadue Open the command line press Win button El and then digit cmd Run cmd exe In the command window type the following line where XYZ has to be replaced with the serial number of your Trentadue netsh wlan set profileparameter TrentadueXYZ ConnectionType ibss 10 As result you should read Profile TrentadueXYZ on interface Wi Fi updated succesfully 11 Close command window v1 3 Ed 11 2015 Pag 11 21 SI OT Bioelettronica snc User Manual IZ elettronica Enter information for the wireless network you want to add Network name Security type No authentication Open v Encryption type None Security Key Hide characters C Start this connection automatically Connect even if the network is not broadcasting Warning If you select this option
10. ed LED switches off A Charge the device for at least 2 hours before to use it Application and acquisition vvith Trentadue To use Trentadue system properly follovv these instructions e connect the selected electrode adapter to the Trentadue device e take the electrodes matrices armband and apply them in direct contact with the investigated muscles v1 3 Ed 11 2015 Pag 9 21 OT Bioelettronica snc User Manual T elettronica e take the snap on connector of the reference cable and connect it to the reference electrode displaced on a point without EMG activity e connect the electrode adapter to the interested electrodes e switch on the Trentadue device using the ON OFF switch e wait fot the Trentadue net creation e connect the pc to the ad hoc net created by Trentadue see Chapter 8 e run the OT BioLab software and proceed with the signal acquisition see OT BioLab SW manual e atthe end of the measurement session remove the electrodes and disconnect them Disconnect the electrode adapter from the Trentadue device and then put the device and its accessories back in its packaging Discard the single use electrodes A The single use electrodes cannot be reused v1 3 Ed 11 2015 Pag 10 21 OT Bioelettronica snc User Manual T elettronica 8 HOW TO CONNECT TRENTADUE TO PC How to connect to Windows 7 PC L 2 Turn on Trentadue Wait the green light stop blinking When the green light is steady ch
11. immim tn in pag 5 ZINTENDEDNSE aaa IS OO RS pag 5 EFEN EUF USE quantias sic da eee rire da E EEE EEA NEN pag 5 USER PRORILE pais ernment eertes E EE EEE NEEE A pag 5 5 SAFETY PRECAUTIONS AND WARNINGS erre pag 6 6 TRENTADUE DEVICE ACCESSORIES wisasescccsvcieessersxcentetrcctseseradanvetneppsariaecastenconieouns pag ds DETAILED DESCRIPTION eines pag 8 IEC CIE adopter earesenistemmmmnmaondseenmymmn amidat pag 9 USB cable for battery charge oi eeoceessaiamestuitseseismmestmb ssmmnits mets pag 9 System requirements for PC connection ssssssesssseseseereserssseresrereseeesseessseee pag 9 Behaviour of the device during battery charge process pag 9 Application and acquisition with Trentadue ccccccssseccceseceeeseceeeeeeeeeees pag 10 8 HOW TO CONNECT TRENTADUE TO PC 2 0 0 eee e ccc cssseeccccceeeeeceecsaeesecceessaaaeeeees pag 11 9 HOW TO UPGRADE FIRMWARE e eeeerererrreeeeeeeennanoo pag 13 10 MATLAB CONNECTION ainsi pn pag 14 11 TROUBLE SHOOTING ciio N pag 16 12 MAINTENANCE AND STORAGE csssisscsusaccsssasussacergeentesssariesaetucaiasstusaareageeniansensieasnes pag 17 CISNE EE Eeetetemenontetaiomtmmmetasinttbenaitmeta estat pag 17 Prod ct disposal eemiciGeatencomiematietea tzimeci miuembssnttsetettmitememiemtteen pag 18 Lifespan of the deViCE EE ANDROID sane EE EE pag 18 13 TECHNICAL SPECIFICATIONS cccccssssssccccceeseccceceeeeseeceseeseeseeceessaeee
12. seeeeeaas pag 19 CUSTOMER SERVICE sssr ssi anari EEEE pag 20 MARRANT saaie a E E E EAE pag 20 v1 3 Ed 11 2015 Pag 4 21 OT Bioelettronica snc User Manual T elettronica 1 GENERAL DESCRIPTION The Trentadue is a 32 channel surface electromyographic EMG device This system has been designed to detect the surface electromyography signal SEMG from skeletal muscles trough the use of the surface electrodes The information detected from the electrodes is then transferred to a PC with a wireless connection WiFi The Trentadue works with a software called OT BioLab in order to display and process the data This software is part of the Trentadue system and it is also possible to download it free on the website www otbioelettronica it in the Downloads section Alternatively it is possible to acquire from Trentadue by directly reading data with a custom software o script further details can be found in this manual 2 INTENDED USE Trentadue has been designed to be used as an electromyography device to detect the activity of skeletal muscles up to 16 muscles simultaneously The device is not intended to be used near inflammable anaesthetics 3 PLACE OF USE Trentadue is intended to be used primarily as a laboratory device and secondly as a hospital device as a home device the patient uses the device at home during the day and as a hospital device in this case the operator uses the information detected in order to make a di
13. sis 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 Trentadue or connection cables with water in autoclave or steam cleaning A The device must not be used in any other vvay than indicated in these instructions v1 3 Ed 11 2015 Pag 6 21 OT Bioelettronica snc User Manual T elettronica 6 TRENTADUE DEVICE ACCESSORIES ACCESSORIES Description USB connection cable to recharge NON B02 USEM internal battery and for PC connection STERILE ISS RBS NON AD1x16TR 16 channels matrixes connection adapter RIUSABILE STERILE NON AD1x32TR 32 channels matrixes connection adapter RIUSABILE STERILE O O O NON AD8x1TR 8 couple electrodes connection adapter STERILE RIUSABILE ADx1TR Single channel bipolar cable with jack NON RIUSABILE concentric connectors STERILE 16 electrodes armband connection NON AB1x16TR Dual channels bipolar cable with jack NON concentric connectors STERILE IDE ADx2TR
14. ss mode In table 1 there are the technical specifications of the Trentadue device DO een mm a a O omnes mim TAB 1 Technical Specifications of the Trentadue v1 3 Ed 11 2015 Pag 19 21 OT Bioelettronica snc User Manual T elettronica A CUSTOMER SERVICE Trentadue 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 OT Bioelettronica will forfeit entitlement to warranty OT Bioelettronica 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 OT Bioelettronica Trentadue does not need any prior maintenance A VVARRANTY OT Bioelettronica ensures that every nevv 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 OT Bioelettronica following the warranty are limited exclusively to what follows reparation will be made by and no later
15. 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 11 2015 Pag 20 21 OT Bioelettronica snc User Manual T elettronica If OT Bioelettronica 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 OT Bioelettronica 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 OT Bioelettronica is that of returning the product to the user at its own expenses Manufactured by OT Bioelettronica C so Unione Sovietica 312 10135 Torino TO ITALY www otbioelettronica it e mail mail otbioelettronica it v1 3 Ed 11 2015 Pag 21 21
16. ttery low or wireless communication samples loss ON OFF switch With this switch it is possible to turn on and off Trentadue v1 3 Ed 11 2015 Pag 8 21 OT Bioelettronica snc User Manual T elettronica Electrode adapters connector to detect the electromyographic signals produced by muscles Trentadue needs one of the following adapters AD8x1TR AD16x1TR AD1x16TR or AD1x32TR The different adapters allow the connection to different electrode matrices arrays or electrode pairs Each adapter incorporates a snap on connector or a connector for a snap on cable for the reference electrode It has to be placed in a point without EMG activity USB cable charge battery cable The Trentadue device has as accessory a USB cable as shown in fig 2 called CUSBO2 This cable allows to charge Trentadue by its connection to a USB PC port or to a power supplier that incorporates an USB output Fig 2 Cable for Trentadue battery charge System Requirements for PC connection 1 Windows Operating system for PC Windows XP Vista Windows 7 Windows 8 Windows 8 1 Windows 10 2 USB port to recharge Trentadue equipment 3 One WiFi board installed in the PC to allow Trentadue wireless connection Behaviour of the device during battery charge process During the battery charge process the red Recharge LED located on the Trentadue right side frontal view becomes red till the end of the recharge process when the battery is fully charged the r
17. with Trentadue device v1 3 Ed 11 2015 Pag 16 21 OT Bioelettronica snc User Manual T elettronica 12 MAINTENANCE AND STORAGE Trentadue 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 Trentadue at the end of every session Trentadue 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 Trentadue 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 1 hour contact the manufacturer to check the controls of the electrical source itself Cleaning the device At the end of every use clean the Trentadue with a clean cloth e A Do not clean Trentadue using acetone ether freon oil products or any other solvent A Do not use soap or vvater on the connectors pin contacts e A Do not clean Trentadue or its cables vvith vvater in autoclave or vvith steam cleaning A VVARNING clean the electrodes adapter cable only vvith hospital disinfectants before every use to avoid microbial contamination betvveen patients and healthcare professionals v1 3
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